Clinical trial NCT00489918: Dose Ranging Study - Macroflux Parathyroid Hormone (PTH) in Postmenopausal Women With Osteoporosis
Official title: A Dose Ranging Study of the Effects of Macroflux® PTH Compared With Macroflux® Placebo and FORTEO® in Postmenopausal Women With Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoporosis
Lead sponsor: Zosano Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2007-06-21
Enrollment: 165
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multi-center study to determine effects of various doses of Macroflux Parathryroid Hormone (PTH) in women with osteoporosis


Eligibility criteria: Inclusion Criteria:

* Healthy postmenopausal women age 50 years or older
* At least three lumbar vertebrae (L1-L4) must be evaluable by dual energy x-ray absorptiometry (DXA) for bone mineral densitometry that is, without fracture or significant degenerative disease, as determined by the central imaging facility
* Have osteoporosis defined as: Either a T-score of ≤ -2.5 at the lumbar spine, femoral neck, or total hip, AND a T-score of at least \< -1.0 at the lumbar spine; or A T-score of ≤ -2.0 at the lumbar spine, femoral neck, or total hip, AND at least one vertebral fracture;

Exclusion Criteria:

* Active hepatitis;
* Active pancreatitis;
* Unstable cardiac disease;
* Unstable pulmonary disease;
* Celiac disease;
* Hyper- or hypo-parathyroidism;
* Hyperthyroidism;
* Cushing's disease;
* Osteomalacia;
* Paget's disease;
* Osteogenesis imperfecta;
* Known blood disorders;
* History of kidney stones;
* Impaired renal function;
* Autoimmune diseases;
* Bone metastases or a history of skeletal malignancies;
* Cancer history that includes any cancer within the previous 5 years, with the exception of squamous or basal cell carcinoma of the skin in which the lesions were fully resected with clear margins described in a written report by a pathologist, and the patient has had no recurrence of lesions for at least 1 year from the time of original resection;
* Any condition or disease that may interfere with the ability to have or the evaluation of a DXA scan, for example, severe osteoarthritis of the spine, spinal fusion, pedicle screws, history of vertebroplasty, or degenerative disease that results in insufficient number of evaluable lumbar vertebrae, or \>1 lumbar vertebral fracture in L1-L4;
* More than 4 vertebral fractures in T4-L4;
* Bilateral hip replacements;
* Use of fluoride (e.g. fluoride therapy for osteoporosis) or strontium at any time;
* Have received methotrexate or immunomodulatory agents with antiproliferative activity;
* With known dermatological disorders that would interfere with the study procedures or assessments, or with a history of contact dermatitis;
* With known allergy or sensitivity to tapes, adhesives, PTH, teriparatide or its analogs, or components of the Macroflux® systems;
* Who, in the opinion of the investigator, should not participate in the study, or may not be capable of following the study schedule for any reason; and
* Unwillingness or inability to abide by the requirements of the study.
* Have received any intravenous (IV) administered bisphosphonates in the past 24 months, or \>2 doses of IV administered bisphosphonates total;
* Use of oral bisphosphonates before randomization, including investigational bisphosphonates, unless: \<6 months of treatment and off for 6 months, or 6-12 months of treatment and off for 2 years, or \>12 months of treatment and off for 5 years;

Primary outcomes:
measure: Percent Change in Lumbar Spine Bone Mineral Density (BMD): Baseline to Week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: Percent Change in Lumbar Spine Bone Mineral Density: Baseline to Week 12
timeFrame: 12 weeks
measure: Absolute Change in Lumbar Spine BMD: Baseline to Week 12
timeFrame: 12 weeks
measure: Percent Change in Total Hip Bone Mineral Density: Baseline to Week 24
timeFrame: 24 Weeks
measure: Percent Change in Femoral Neck BMD: Baseline to Week 24
timeFrame: 24 Weeks
Other outcomes:
Locations:
Study officials:
affiliation: Zosano Pharma Corporation
name: Thorsten von Stein, MD, Ph.D
role: STUDY_DIRECTOR
References:
citation: Cosman F, Lane NE, Bolognese MA, Zanchetta JR, Garcia-Hernandez PA, Sees K, Matriano JA, Gaumer K, Daddona PE. Effect of transdermal teriparatide administration on bone mineral density in postmenopausal women. J Clin Endocrinol Metab. 2010 Jan;95(1):151-8. doi: 10.1210/jc.2009-0358. Epub 2009 Oct 26.