Clinical trial NCT00172081: TOP: Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis
Official title: An 18-Month Double-Blind, Placebo-Controlled, Phase III, Trial With a 12-Month Interim Analysis of the Effect of Recombinant Human Parathyroid Hormone (ALX1-11) on Fracture Incidence in Women With Postmenopausal Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Post-menopausal
Osteoporosis
Parathyroid Hormone
PTH
ALX1-11
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 2532
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an 18-month, double-blind, placebo-controlled, Phase III trial with a 12-month interim analysis of the effect of ALX1-11, recombinant human parathyroid hormone (1-84) (rhPTH \[1-84\]), on fracture incidence in women with postmenopausal osteoporosis, the TOP study.

Detailed description: Parathyroid hormone (PTH), a polypeptide consisting of 84 amino acids that is synthesized and secreted by the parathyroid glands, is a principal regulator of calcium homeostasis through concerted action on kidney, intestine and bone. Parathyroid hormone exerts its action on bone to release calcium into the extracellular fluid as a process of bone remodeling and also to maintain the serum calcium concentration, but the exact mechanisms are not fully understood. In some circumstances, PTH may exert an anabolic action on bone and can stimulate osteoblast proliferation and mature osteoblast function. The net effect of exogenous PTH administration on bone turnover depends on the pattern of delivery. A continuous long-term infusion gives a net decrease in trabecular bone volume, whereas daily single injections result in a net increase.

NPS Allelix Corp. is developing ALX1-11, recombinant human parathyroid hormone (1-84), for the treatment of osteoporosis. ALX1-11 is identical to the endogenous intact 84 amino acid human hormone and will be self-administered on a daily basis by subcutaneous (sc) injection.

Currently, there is no approved therapy for osteoporosis capable of stimulating the formation of new bone of normal composition and structure. Most therapies in development are anti-catabolic and only prevent further bone loss (e.g., estrogen replacement, bisphosphonates, and calcitonins). ALX1-11 has the potential to stimulate new bone formation in osteoporotic patients, thereby increasing bone mass and preventing fractures. Patients with moderately or severely reduced bone density and a fracture would be expected to benefit from treatment, thereby improving functional status and alleviating symptoms.

Eligibility criteria: Inclusion Criteria:

* Women who are postmenopausal with at least one year since the last menstruation.
* Women who are 45-54 years of age with the following bone mineral density (BMD) and/or vertebral fracture:

  * BMD 3.0 standard deviations (SDs) or more below peak bone mass of young females at the lumbar spine, femoral neck, or total hip; or
  * BMD 2.5 SDs or more below peak bone mass of young females at the lumbar spine, femoral neck or total hip with the presence of a vertebral fracture verified by the central imaging organization before the patient is enrolled into the study.
* Women 55 or more years of age with the following BMD and/or vertebral fracture:

  * BMD 2.5 SDs or more below peak bone mass of young females at the lumbar spine, femoral neck or total hip; or
  * BMD 2.0 SDs or more below peak bone mass of young females at the lumbar spine, femoral neck or total hip with the presence of a vertebral fracture verified by the central imaging organization before the patient is enrolled into the study.
* The following types of vertebral fractures should not be considered for patient enrollment into this trial:

  * Pathological fractures due to malignant disease or infection
  * Fractures due to excessive trauma sufficient to cause a fracture in young individuals with normal bone mass
* Women with the ability to self-administer a daily injection or have a designee who will give the injections
* Women who are capable of understanding and giving written, voluntary informed consent before the clinical trial screening visit

Exclusion Criteria:

A. Vertebral Deformity:

* Patient has 5 or more vertebral (thoracic and lumbar) deformities
* Patient has 2 or more lumbar vertebral deformities (L1 to L4)
* Severe lumbar scoliosis (\>15 degrees) which precludes a reliable evaluation of the dual x-ray absorptiometry (DXA)

B. DXA Imaging:

* Inability to have a DXA scan performed.

C. History or Concurrent Illness:

* Disorders of immunity
* Endocrine system
* Gastrointestinal system
* Kidney and collecting system
* Liver, biliary tract and pancreatic systems
* Musculoskeletal system
* Neoplasia
* Nervous system
* Vascular, respiratory and cardiac system
* Significant diseases or disorders are determined by history, physical exam or laboratory screens and judged by the Principal Investigator to be significant.

D. Concurrent Medication:

Any patient who does not require medication washout (discontinuation) as specified below may start study drug dosing after 2 weeks of stabilization treatment with calcium and vitamin D3 supplements. All exceptions will be documented in the case report form (CRF).

* Patients cannot be enrolled into this clinical trial if they have received any of the following therapies at any time:

  * Any PTH or PTH analogs \[e.g., rhPTH(1-84), PTH(1-34), PTHrP and analogs\]
  * Fluoride
  * Strontium
* Patients must have been off the following agents for the specified times before entering the screening phase of this clinical trial:

  * Any investigational drug (30 days)
  * Anabolic steroids or androgens (6 consecutive months)
  * Active vitamin D3 metabolites and analogs(90 days)
  * Systemic corticosteroids, more than 5 mg/day prednisone or a systemic corticosteroid formulation equivalent to 5 mg/day prednisone (12 consecutive months).
  * A patient who has been enrolled in the study and needs to receive an acute bolus of steroids (oral or injectable) for a self-limited illness may continue treatment in the study if the following requirements are met:

    1. Exposure to steroids is limited to no more than 30 consecutive days
    2. The maximal dose of steroid (prednisone equivalent) is limited to no more than 225 mg (7.5 mg each day for 30 days)
    3. The illness is acute in nature and is not expected to recur during the remaining treatment period of the study
  * Daily inhaled corticosteroids unless dose is below 1200 mg/day of beclomethasone.
  * Bisphosphonates, including investigational bisphosphonates.
  * Intravenous (IV) pamidronate. Patient must be receiving pamidronate specifically to treat osteoporosis. Patient can have received only ONE IV dose of pamidronate in the 12 months immediately preceding the screening visit.
  * Cyclical etidronate. Exposure to cyclical etidronate must be less than or equal to 6 months on a standard dose (e.g. 400 mg/day). Patient should not have exposure to cyclical etidronate for 9 months prior to the screening visit.
  * Phenytoin for seizure control. If the patient has received phenytoin within five years of the screening visit, the patient is excluded from this study. The patient may continue in the screening process if 15 years have passed since the last dose of phenytoin at the time of the screening visit. If the phenytoin use was between 5-15 years before the screening visit and the patient received phenytoin for less than 2 months.
* Patients may be enrolled if they have been stabilized on the following therapy for the specified amount of time:

  \* Thyroid hormone (\<0.1 mg/day thyroxine) therapy for at least 6 months. \* Stable dosage of thiazide for at least 3 consecutive months.
* All patients must stop the following therapies at least 4 weeks prior to the screening visit and remain off these therapies for the remainder of the clinical trial. Screening laboratories must be performed after the washout is complete. However, imaging studies (BMD, X-rays) may be performed prior to starting the calcitonin, estrogen, and selective estrogen receptor modulation (SERM) washout.

  * Calcitonin
  * Estrogen replacement therapy by oral, transdermal or intramuscular administration
  * SERM drugs, e.g., tamoxifen, raloxifene, Evista
  * Vaginal application of estrogen-containing creams unless the dose is conjugated estrogen or estradiol\* Cytostatics, e.g., azathioprine, recombinant human tumor necrosis fusion (Fc) protein, monoclonal antibody against tumor necrosis factor (e.g., remicade \[infliximab\])
  * The drug class tetracyclines
  * Medication known to affect the metabolism of bone (the Principal Investigator should discuss this with the Project Medical Officer before the patient is excluded from enrollment)

E. Miscellaneous Concurrent Medications:

* Methotrexate
* Intra-articular injections - Patients with chronic, active joint disease should be excluded from this Phase III study. Patients may receive a maximum of one intra-articular injection (ONE JOINT ONLY) every 6 months while participating in this Phase III study. The dose of corticosteroid injected should not exceed the anti-inflammatory equivalent dose of prednisone 40 mg suspension. The dose and volume should be adjusted downward as appropriate to the size of the joint.
* Provera is an acceptable concomitant medication when used according to the label instructions.

F. Laboratory Values and Physical Examination Findings:

* Serum calcium greater than 10.7 mg/dL (2.66 mmol/L). At screening, if the serum calcium is abnormal, the patient may have the additional evaluation described below ONCE:

  1. Discontinue all oral calcium and vitamin D3 supplements.
  2. Repeat a fasting serum calcium level two weeks later.
  3. If the fasting serum calcium level is still abnormal, the patient is discontinued from the study.
  4. If the repeat fasting serum calcium is normal, the patient should have supplemental calcium and vitamin D3 restarted at the time of study drug dosing, without going through a two-week stabilization period.
* Serum creatinine \> 1.5 mg/dL (132.6 mmol/L)
* Urinary calcium to creatinine ratio is greater than or equal to 1. At screening, if a patient's urinary calcium to creatinine ratio is abnormal, the patient may have the additional evaluation described below ONCE:

  1. Discontinue all oral calcium and vitamin D3 supplements.
  2. Repeat a fasting urine calcium to creatinine ratio two weeks later.
  3. If the fasting urinary calcium to creatinine ratio is still abnormal, the patient is discontinued from the study.
  4. If the repeat fasting urinary calcium to creatinine ratio is normal, the patient should have supplemental calcium and vitamin D3 restarted at the time of study drug dosing, without going through a two-week stabilization period.
* Total serum alkaline phosphatase \>130 U/L except as noted - Argentina (311 U/L); Brazil (278 U/L); Mexico (159 U/L).
* Any other clinically significant abnormal value as judged by the investigator
* Body weight below 40 kg

G. Substance Abuse:

* Alcohol and/or drug abuse

H. Psychiatric Disease:

* Current or history of psychiatric disease that would interfere with the ability to comply with the clinical trial protocol

I. Compliance:

* Suspected or confirmed poor compliance in completing clinical trial evaluations and/or clinical trial required questionnaires

Primary outcomes:
measure: Compare effects of 18 months of treatment with ALX1-11/placebo on the incidence of new and/or worsened thoracic and lumbar vertebral fractures in postmenopausal women with osteoporosis receiving calcium and vitamin D3 supplements
timeFrame: At Month 18
Secondary outcomes:
measure: Incidences of vertebral fractures at Month 12; hip and wrist fractures; and other clinical fractures.
timeFrame: At Month 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Capstone Clinical Trials
state: Alabama
city: Birmingham
country: United States
facility: 'The University of Alabama at Birmingham
state: Alabama
city: Huntsville
country: United States
facility: 'Rheumatology Associates of North Alabama
state: Alabama
city: Phoenix
country: United States
facility: 'Radiant Research - Phoenix
state: Arizona
city: Anaheim
country: United States
facility: 'Robin K. Dore, M.D., Inc.
state: California
city: Beverly Hills
country: United States
facility: 'Osteoporosis Medical Center
state: California
city: Concord
country: United States
facility: 'East Bay Clinical Trial Center
state: California
city: Loma Linda
country: United States
facility: 'Loma Linda Osteoporosis Research Center
state: California
city: Oakland
country: United States
facility: 'The Foundation for Osteoporosis Research and Education
state: California
city: Palm Desert
country: United States
facility: 'Desert Medical Advances
state: California
city: Palo Alto
country: United States
facility: 'VA Palo Alto Health Care System
state: California
city: Rancho Cucamonga
country: United States
facility: 'Boling Clinical Trials
state: California
city: San Diego
country: United States
facility: 'Radiant Research - San Diego
state: California
city: San Diego
country: United States
facility: 'S.D. Arthritis & Osteoporosis Medical Clinic
state: California
city: San Francisco
country: United States
facility: 'San Francisco General Hospital
state: California
city: Santa Ana
country: United States
facility: 'Community Research Centers
state: California
city: Denver
country: United States
facility: 'Denver Arthritis Clinic
state: Colorado
city: Lakewood
country: United States
facility: 'Colorado Center for Bone Research
state: Colorado
city: Longmont
country: United States
facility: 'Longmont Medical Research Network
state: Colorado
city: Hamden
country: United States
facility: 'Northeast Clinical Research, LLC
state: Connecticut
city: Washington
country: United States
facility: 'Georgetown University Medical Center
state: District of Columbia
city: Boca Raton
country: United States
facility: 'RASF - Clinical Research Center
state: Florida
city: Fort Myers
country: United States
facility: 'ICSL Clinical Studies
state: Florida
city: Hollywood
country: United States
facility: 'The Center for Diabetes and Endocrine Care
state: Florida
city: Inverness
country: United States
facility: 'Florida Wellcare Alliance
state: Florida
city: Lake Worth
country: United States
facility: 'Radiant Research - Lake Worth
state: Florida
city: Miami
country: United States
facility: 'Osteoporosis Center University of Miami
state: Florida
city: Ocala
country: United States
facility: 'Renstar Medical Group
state: Florida
city: Palm Beach Gardens
country: United States
facility: 'Diabetes and Endocrinology Treatment Center
state: Florida
city: Palm Harbor
country: United States
facility: 'The Arthritis Center
state: Florida
city: Saint Petersburg
country: United States
facility: 'ICSL Clinical Studies
state: Florida
city: South Miami
country: United States
facility: 'The Centre for Arthritis and Rheumatic Diseases
state: Florida
city: Stuart
country: United States
facility: 'Radiant Research - Stuart & LakeWorth
state: Florida
city: West Palm Beach
country: United States
facility: 'Palm Beach Research Center
state: Florida
city: Atlanta
country: United States
facility: 'The Emory Clinic
state: Georgia
city: Honolulu
country: United States
facility: 'Radiant Research
state: Hawaii
city: Boise
country: United States
facility: 'Intermountain Orthopaedics
state: Idaho
city: Bloomington
country: United States
facility: 'ICSL-Clinical Studies
state: Illinois
city: Chicago
country: United States
facility: Rush-Prebyterian-St.Luke's Medical Center
state: Illinois
city: Chicago
country: United States
facility: 'The University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: 'University Hospital & Outpatient Center
state: Indiana
city: Des Moines
country: United States
facility: 'Mercy Arthritis and Osteoporosis Center
state: Iowa
city: Wichita
country: United States
facility: 'Wichita Clinic
state: Kansas
city: New Orleans
country: United States
facility: 'Ochsner Clinic
state: Louisiana
city: Bangor
country: United States
facility: 'Maine Center for Osteoporosis Research & Education
state: Maine
city: Bethesda
country: United States
facility: 'Bethesda Health Research Center
state: Maryland
city: Cumberland
country: United States
facility: 'The Osteoporosis and Clinical Trials Center
state: Maryland
city: Frederick
country: United States
facility: 'Arthritis & Osteoporosis Center of Maryland
state: Maryland
city: Hagerstown
country: United States
facility: 'The Osteoporosis and Clinical Trials Center
state: Maryland
city: Wheaton
country: United States
facility: 'The Center for Rheumatology and Bone Research
state: Maryland
city: Boston
country: United States
facility: 'Brigham & Women's Hospital
state: Massachusetts
city: Fall River
country: United States
facility: 'Phase III Clinical Research
state: Massachusetts
city: Worcester
country: United States
facility: 'Osteoporosis Research & Treatment Center
state: Massachusetts
city: Detroit
country: United States
facility: 'Michigan Bone & Mineral Clinic
state: Michigan
city: Olive Branch
country: United States
facility: 'Desoto Family Medical Center
state: Mississippi
city: Springfield
country: United States
facility: 'St. John's Medical Research Group
state: Missouri
city: Las Vegas
country: United States
facility: 'VA Southern NV Healthcare Systems
state: Nevada
city: Concord
country: United States
facility: 'Arthritis, Osteoporosis Muscle Skeletal Disease Center
state: New Hampshire
city: Berlin
country: United States
facility: 'Comprehensive Clinical Research
state: New Jersey
city: South Plainfield
country: United States
facility: 'Anderson and Collins Clinical Research Inc.
state: New Jersey
city: Albuquerque
country: United States
facility: 'New Mexico Clinical Research and Osteoporosis Center
state: New Mexico
city: Albuquerque
country: United States
facility: 'Lovelace Scientific Resources
state: New Mexico
city: Mineola
country: United States
facility: 'Bone Mineral Research Center
state: New York
city: New York
country: United States
facility: 'Beth Israël Medical Center
state: New York
city: New York
country: United States
facility: 'College of Physicians and Surgeons, Columbia University
state: New York
city: Rochester
country: United States
facility: 'Rochester Clinical Research Inc.
state: New York
city: Stony Brook
country: United States
facility: 'Stony Brook Clinical Research Trials Center
state: New York
city: White Plains
country: United States
facility: 'Physicians Clinical Research Services
state: New York
city: Charlotte
country: United States
facility: 'Carolina Bone and Joint - Charlotte
state: North Carolina
city: Durham
country: United States
facility: 'Duke University Medical Center
state: North Carolina
city: Bismarck
country: United States
facility: 'Odyssey Research Services
state: North Dakota
city: Fargo
country: United States
facility: Michael J. Lillestol
state: North Dakota
city: Grand Forks
country: United States
facility: 'Altru Health Systems/Altru Research Center
state: North Dakota
city: Minot
country: United States
facility: 'Odyssey Research Services
state: North Dakota
city: Cleveland
country: United States
facility: 'Cleveland Clinic Foundation
state: Ohio
city: Mayfield
country: United States
facility: 'David R. Mandel M.D. Inc.
state: Ohio
city: Tulsa
country: United States
facility: 'Oklahoma Center for Arthritis Therapy & Research, Inc.
state: Oklahoma
city: Medford
country: United States
facility: 'Osteoporosis Center
state: Oregon
city: Duncansville
country: United States
facility: 'Altoona Center for Clinical Research
state: Pennsylvania
city: Philadelphia
country: United States
facility: 'Thomas Jefferson University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: 'University of Pittsburgh Medical Center
state: Pennsylvania
city: West Reading
country: United States
facility: 'Clinical Research Center of Reading LLP
state: Pennsylvania
city: Wyomissing
country: United States
facility: 'Radiant Research
state: Pennsylvania
city: Providence
country: United States
facility: 'Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: 'Roger Williams Medical Center
state: Rhode Island
city: Anderson
country: United States
facility: 'Radiant Research
state: South Carolina
city: Columbia
country: United States
facility: 'Columbia Arthritis Center, PA
state: South Carolina
city: Greer
country: United States
facility: 'Radiant Research
state: South Carolina
city: Rapid City
country: United States
facility: 'Rapid City Medical Center
state: South Dakota
city: Sioux Falls
country: United States
facility: 'Averna Research Institute
state: South Dakota
city: Watertown
country: United States
facility: 'Brown Clinic
state: South Dakota
city: Chattanooga
country: United States
facility: 'Clinsearch
state: Tennessee
city: Dallas
country: United States
facility: 'Radiant Research/Dallas
state: Texas
city: Houston
country: United States
facility: 'Breco Research Inc.
state: Texas
city: Midland
country: United States
facility: 'Diabetes Center of the Southwest
state: Texas
city: San Antonio
country: United States
facility: 'Diabetes & Glandular Disease Research Associates, P.A.
state: Texas
city: San Antonio
country: United States
facility: 'Radiant Research San Antonio
state: Texas
city: Sandy
country: United States
facility: 'Salt Lake Women's Center
state: Utah
city: Burlington
country: United States
facility: 'Fletcher Allan Health Center, UHC Campus 1
state: Vermont
city: Newport News
country: United States
facility: 'Center for Arthritis and Diabetes
state: Virginia
city: Richmond
country: United States
facility: 'National Clinical Research, Inc.
state: Virginia
city: Richmond
country: United States
facility: 'MCV Physicians Program for Osteoporosis
state: Virginia
city: Olympia
country: United States
facility: 'South Puget Sound Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Phillip J. Mease
state: Washington
city: Seattle
country: United States
facility: 'Osteoporosis Research Group
state: Washington
city: Madison
country: United States
facility: 'University of Wisconsin Medical Foundation
state: Wisconsin
city: Milwaukee
country: United States
facility: 'Medical College of Wisconsin
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: 'IDIM
state: BUE
city: Buenos Aires
country: Argentina
facility: 'Centro Médico T.I.E.M.P.O
state: BUE
city: Buenos Aires
country: Argentina
facility: 'Hospital Ramos Mejía
state: BUE
city: Capital Federal
country: Argentina
facility: 'Centro de Osteopatias Medicas
state: CBA
city: Recife
country: Brazil
facility: 'Universidade Federal de Pernambuco
state: PE
city: Curitiba
country: Brazil
facility: 'Universidade Federal do Paraná
state: PR
city: 'Rio de Janeiro
country: Brazil
facility: 'Hospital Santa Casa de Misericórdia do Rio de Janeiro
state: RJ
city: Rio de Janeiro
country: Brazil
facility: 'Hospital do Servidor Público do Rio de Janeiro
state: RJ
city: Campinas
country: Brazil
facility: 'UNICAMP
state: SP
city: Campinas
country: Brazil
facility: 'Pontifícia Universidade Católica de Campinas
state: SP
city: Sao Paulo
country: Brazil
facility: 'Hospital Santa Casa de Misericórdia de São Paulo
state: SP
city: Sao Paulo
country: Brazil
facility: 'Universidade Federal de São Paulo
state: SP
city: Sao Paulo
country: Brazil
facility: 'Instituto de Saúde e Bem Estar da Mulher
state: SP
city: Sao Paulo
country: Brazil
facility: 'Hospital Heliópolis
state: SP
city: Plovdiv
country: Bulgaria
facility: 'Multifunctional Hospital for Active Treatment "Sv.Georgy"
city: Sofia
country: Bulgaria
facility: 'SHATENG"Acad.Ivan Penchev"
city: Sofia
country: Bulgaria
facility: 'Multifunctional Hospital for Active Treatment "Alexandrovska
city: Sofia
country: Bulgaria
facility: 'Multifunctional Hospital for Active Treatment "Sv.Ivan Rilsky"
city: Sofia
country: Bulgaria
facility: 'SHATGO"Sheynovo"
city: Calgary
country: Canada
facility: 'Heritage Medical Research Clinic
state: Alberta
city: Vancouver
country: Canada
facility: Osteoporosis Research Center
state: British Columbia
city: Winnipeg
country: Canada
facility: 'Manitoba Clinic
state: Manitoba
city: Hamilton
country: Canada
facility: Charlton Medical Centre
state: Ontario
city: Kitchener
country: Canada
facility: Rafat Faraawi
state: Ontario
city: London
country: Canada
facility: 'Centre for Activity and Aging
state: Ontario
city: London
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
city: Montreal
country: Canada
facility: 'Royal Victoria Hospital
state: Ontario
city: Oakville
country: Canada
facility: Oakville Bone Center
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: 'Sunnybrook and Women's College Health Science Center
state: Ontario
city: Toronto
country: Canada
facility: 'St. Michael's Hospital
state: Ontario
city: Toronto
country: Canada
facility: 'Osteoporosis Research Program
state: Ontario
city: Windsor
country: Canada
facility: Jude F. Rodrigues
state: Ontario
city: Charlottetown
country: Canada
facility: 'Riverside Medical Centre
state: Prince Edward Island
city: Chicoutimi
country: Canada
facility: 'Complexe Hospitalier de la Sagami
state: Quebec
city: Montreal
country: Canada
facility: 'Centre d'Etude Clinique Montreal Inc.
state: Quebec
city: Montreal
country: Canada
facility: 'Hopital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: 'Centre de Recherche du CHUM - Hopital Saint-Luc
state: Quebec
city: Sainte-Foy
country: Canada
facility: Centre de Recherche - CORQ
state: Quebec
city: Sherbrooke
country: Canada
facility: Novabyss Research Clinic
state: Quebec
city: 'Saskatoon
country: Canada
facility: 'Saskatoon Osteoporosis Centre
state: Saskatchewan
city: Beer Sheva
country: Israel
facility: 'Soroka Medical Center
city: Beer Sheva
country: Israel
facility: 'Clalit Health Services
city: Hadera
country: Israel
facility: 'Hillel Yaffe Medical Center
city: Haifa
country: Israel
facility: 'Rambam Medical Center
city: Haifa
country: Israel
facility: 'Lin Medical Center
city: Jerusalem
country: Israel
facility: 'Hadassah University Hospital
city: Petach Tikva
country: Israel
facility: 'Rabin Medical Center
city: Ramat Gan
country: Israel
facility: 'Chaim Sheba Medical Center
city: Tel Aviv
country: Israel
facility: 'Lis Maternity Hospital
city: Chihuahua
country: Mexico
facility: 'Hospital Clinical del Parque
state: Chih
city: Mexico
country: Mexico
facility: 'Osteosol
state: DF
city: Mexico
country: Mexico
facility: 'Instituto Mexicano de Investigacion Clinica
state: DF
city: Mexico
country: Mexico
facility: 'Hospital de Mexico
state: DF
city: 'Huixquilucan
country: Mexico
facility: 'Hospital Angeles de las Lomas
state: Emex
city: Leon
country: Mexico
facility: 'Hospital Aranda de la Parra
state: GTO
city: Guadalajara
country: Mexico
facility: 'OPD Hospital Civil de Guadalajara Dr. Juan I. Menchaca
state: JAL
city: Guadalajara
country: Mexico
facility: 'Hospital Civil de Belem
state: JAL
city: Guadalajara
country: Mexico
facility: 'Medica Monraz
state: JAL
city: 'San Luis Potosi
country: Mexico
facility: 'Hospital Central "Ignacio Morones Prieto"
state: SLP
city: Monterrey Nuevo Leon
country: Mexico
facility: 'Hospital Universitario de Monterrey
city: Bucuresti
country: Romania
facility: 'CLINTRIAL "DORIS" Medical Centre
city: Bucuresti
country: Romania
facility: 'Centrul Medical Sabyc
city: Cluj-Napoca
country: Romania
facility: 'Spitalul Clinic Judetean Cluj-Napoca
city: Moscow
country: Russian Federation
facility: 'Scientific Center of Endocrinology of RAMS
city: Moscow
country: Russian Federation
facility: 'JK "Medicine"
city: Moscow
country: Russian Federation
facility: 'Russian Academy for Advanced Medical Studies
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Greenspan SL, Bone HG, Ettinger MP, Hanley DA, Lindsay R, Zanchetta JR, Blosch CM, Mathisen AL, Morris SA, Marriott TB; Treatment of Osteoporosis with Parathyroid Hormone Study Group. Effect of recombinant human parathyroid hormone (1-84) on vertebral fracture and bone mineral density in postmenopausal women with osteoporosis: a randomized trial. Ann Intern Med. 2007 Mar 6;146(5):326-39. doi: 10.7326/0003-4819-146-5-200703060-00005.