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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00500409

Enrollment

Registered

2007-07-12

Start date

2005-12-31

Completion date

2007-07-31

Last updated

2014-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Keywords

rhPTH(1-34), Osteoporosis

Brief summary

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

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.

Interventions

DRUGOsteoform

Administer Osteoform 20 µg daily subcutaneously and 1000 mg calcium and 500 IU vitamin D orally for 180 days

DRUGSHELCAL

Administer calcium and vitamin D (1000 mg calcium and 500 IU vitamin D) orally for 180 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

45 Years to 75 Years

Healthy volunteers

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

1. Women with vertebral (L1-L4) abnormalities that preclude accurate measurement by DEXA. 2. Women on medications that are known to affect bone for more than 7 days in the past 6 months. 3. Currently taking systemic prednisone, inhaled steroids, anticoagulants, anticonvulsants. 4. History of rhPTH use or known hypersensitivity to study drug. 5. Vitamin D3 deficiency (Vitamin D3 \< 20 ng/ml). 6. Abnormal thyroid function. 7. History of kidney disease. 8. Any history of hypercalciuria, hypercalcemia or hyperparathyroidism. 9. History of active or treated tuberculosis or significant liver disease or gastrointestinal disease or cancer.

Design outcomes

Primary

Measure	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

Measure	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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026