Clinical trial NCT00431444: Effects of Zoledronic Acid and Raloxifene on Bone Turnover Markers in Postmenopausal Women With Low Bone Mineral Density
Official title: A Multi-center, Randomized, Double-blind, Double-dummy Study in Postmenopausal Women With Low Bone Mineral Density to Compare the Effects of a Single Dose of i.v. Zoledronic Acid 5 mg, With Daily Oral Raloxifene 60 mg OD on Bone Turnover Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Keywords: Osteoporosis
Post-menopausal
Bone mineral density
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-02-05
Enrollment: 110
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare the effects of Zoledronic acid and Raloxifene in reducing bone turnover markers in postmenopausal women with low bone mineral density over 6 months.


Eligibility criteria: Inclusion Criteria:

* Females, between 45 and 80 years (inclusive) of age, considered post-menopausal according to one of the following guidelines:
* Cessation of menses for 18 months in women \< 50 years of age
* Cessation of menses for 12 months in women age 50 years or over
* Documented bilateral oophorectomy at least 1 year previously
* Documented T score of less than or equal to -1.5 on dual energy X-ray absorptiometry (DXA) scan at the lumbar spine, total hip or femoral neck within 24 months prior to screening, and clinically indicated for treatment with bisphosphonates (BPs) for osteopenia or osteoporosis
* Signed informed consent prior to initiation of any study procedure

Exclusion Criteria:

* Prior treatment with i.v. bisphosphonates within the last 2 years
* Previous use of oral bisphosphonates within the past 2 years (unless used for less than 8 weeks\*).
* \*NOTE: If used less than 8 weeks, the washout period is 6 months.
* Treatment with raloxifene, calcitonin, tibolone or hormone replacement therapy. The washout period for these medications is 6 months prior to randomization.
* Any treatment with strontium renalate, sodium fluoride or parathyroid hormone
* Use of systemic high dose corticosteroids at an average dose of ≥ 7.5 mg per day of oral prednisone or equivalent for a period of three months or more within the previous year
* Treatment with any investigational drug within 30 days prior to randomization
* Any woman of child bearing potential
* Patients with fractures occurring within three months prior to randomization
* History of hypersensitivity to bisphosphonates
* History of non-traumatic uveitis or iritis, within 2 years prior to study entry.
* A history of invasive malignancy of any organ system, treated or untreated, within the past 12 months prior to screening; excluding, basal cell or squamous cell carcinoma of the skin, colonic polyps with non-invasive malignancy which have been removed, Ductal Carcinoma in-situ (DCIS) that has been surgically removed, and Carcinoma in-situ (CIS) of the uterine cervix that has been surgically removed.
* Previous major solid organ transplant recipient or on a transplant waiting list
* History of hyperparathyroidism, hypoparathyroidism, Osteogenesis imperfecta, Paget's disease or any metabolic bone disease other than osteoporosis
* Any medical condition which would interfere with the action of the study drug or limit life expectancy to less than 6 months
* Any medical or psychiatric condition which, in the opinion of the investigator, would preclude the participant from adhering to the protocol or completing the trial
* Active dental infection, unhealed dental extraction or planned oral surgery within 3 month prior to randomization.
* Calculated creatinine clearance \< 30 mL/min
* Greater than 2+ protein on urine dipstick without evidence of contamination or bacteriuria (may be repeated one time, at least a day apart).
* Serum calcium \> 2.75 mmol/L (11.0 mg/dL) or \< 2.08 mmol/L (8.3 mg/dL) at screening
* AST, ALT or serum alkaline phosphatase greater than twice the upper limit of normal

Primary outcomes:
measure: Change From Baseline in Urine N-telopeptide of Type 1 Collagen (NTx.)
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change From Baseline in Urine NTx at 2 Months
timeFrame: Baseline and 2 months
measure: Change From Baseline in Urine NTx at 4 Months
timeFrame: Baseline and 4 months
measure: Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 2 Months
timeFrame: Baseline and 2 months
measure: Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 4 Months
timeFrame: Baseline and 4 months
measure: Change From Baseline in Serum Bone Specific Alkaline Phosphatase (BSAP) at 6 Months
timeFrame: Baseline and 6 months
measure: Overall Principal Investigator Satisfaction Assessed by Satisfaction Questionnaire
timeFrame: Immediately after infusion procedure
measure: Overall Nurse Satisfaction Assessed by Satisfaction Questionnaire
timeFrame: Immediately after infusion procedure
measure: Overall Patient Satisfaction Assessed by Satisfaction Questionnaire
timeFrame: Immediately after infusion procedure
measure: Patient Preference at 6 Months for Annual i.v Therapy or Daily Oral Regimens
timeFrame: At 6 month visit
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Women's Health Research
state: Arizona
city: Buena Park
country: United States
facility: Associated Pharma Research Center
state: California
city: Washington
country: United States
state: District of Columbia
city: Jacksonville
country: United States
facility: Jacksonville Center for Clinical Research
state: Florida
city: Jacksonville
country: United States
facility: Women's Physicians of Jacksonville
state: Florida
city: Tampa
country: United States
facility: Tampa Clinical Research
state: Florida
city: Springfield
country: United States
facility: Springfield Clinic
state: Illinois
city: St Louis
country: United States
facility: Consultants in Women's Health Care
state: Missouri
city: Omaha
country: United States
facility: Alegent Health
state: Nebraska
city: Pahrump
country: United States
facility: Specialty Medical and Research Center
state: Nevada
city: New Brunswick
country: United States
facility: UMDNJ-Robert Wood Johnson Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University
state: New York
city: Burlington
country: United States
facility: Kernodle Clinic, Inc.
state: North Carolina
city: Portland
country: United States
facility: The Portland Clinic
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Fort Worth
country: United States
facility: Texas Institute for Clinical Research
state: Texas
city: Renton
country: United States
facility: Valley Women's Health Clinic
state: Washington
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Bachmann G, Kriegman A, Goncalves J, Kianifard F, Warren M, Simon JA. Effect of zoledronic acid compared with raloxifene on bone turnover markers in postmenopausal women with low bone density. Menopause. 2011 Aug;18(8):851-6. doi: 10.1097/gme.0b013e31820b80f1.