Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis

Study Overview
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Brief Summary
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OSTEOFORM, containing recombinant (rhPTH [1-34]), enhances bone mineral density and reduces risk for vertebral fracture. This study evaluates the safety and efficacy of OSTEOFORM in the treatment of osteoporosis in post-menopausal women.

Detailed Description
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207 post-menopausal women were enrolled for screening at 6 centres, and supplemented with daily 1000 mg elemental calcium and 500 IU of vitamin D for 45 days. 82 eligible women with osteoporosis were randomly received daily either calcium and vitamin D alone (control group) or Osteoform 20 µg subcutaneously with calcium and vitamin D (drug group) for 12 months. End points such as percentage of increase in bone mineral density and, changes in bone biomarkers (serum osteocalcin, bone specific alkaline phosphatase, and urinary DPD) were evaluated at baseline, and 6 and 12 months after supplementation. Besides, safety parameters and adverse events were monitored through out the study period.

Official Title
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Safety and Efficacy of OSTEOFORM (rhPTH [1-34]) in Increasing Bone Mineral Density in Osteoporosis. A Randomized Controlled Open-label Multicentre Study in India

Conditions
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Osteoporosis

Intervention / Treatment
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* Drug: Osteoform
* Drug: SHELCAL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Postmenopausal women with osteoporosis (Lumbar spine or femoral neck BMD or total hip T-score less than or equal to-2.5) Exclusion Criteria: Women with vertebral (L1-L4) abnormalities that preclude accurate measurement by DEXA. Women on medications that are known to affect bone for more than 7 days in the past 6 months. Currently taking systemic prednisone, inhaled steroids, anticoagulants, anticonvulsants. History of rhPTH use or known hypersensitivity to study drug. Vitamin D3 deficiency (Vitamin D3 < 20 ng/ml). Abnormal thyroid function. History of kidney disease. Any history of hypercalciuria, hypercalcemia or hyperparathyroidism. History of active or treated tuberculosis or significant liver disease or gastrointestinal disease or cancer.

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Drug Group<br>Osteoform | Drug: Osteoform<br>* Administer Osteoform 20 µg daily subcutaneously and 1000 mg calcium and 500 IU vitamin D orally for 180 days<br>|
| Active Comparator: Control group<br>SHELCAL | Drug: SHELCAL<br>* Administer calcium and vitamin D (1000 mg calcium and 500 IU vitamin D) orally for 180 days<br>* Other names: Calcium and vitamin D;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of change in Bone Mineral Density at lumber spine (L1-L4) in postmenopausal women with osteoporosis at the end of 6 and 12 months. |  | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of change from baseline in biomarkers of bone formation and bone resorption at the end of 3, 6 and 12 months. |  | 3, 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rhPTH(1-34), Osteoporosis