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

Phase 3

Completed

• Conditions: Osteoporosis
• Interventions: Drug: Osteoform; Drug: SHELCAL

• Registration Number: NCT00500409
• Lead Sponsor: Virchow Group

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.

Study Timeline

• Study Start: 2005-12
• Primary Completion: 2006-12
• Status Verified: 2007-07
• Study Completion: 2007-07
• Study First Submitted: 2007-07-11
• Study First Submitted QC: 2007-07-11
• Study First Posted: 2007-07-12
• Last Update Submitted: 2014-12-15
• Last Update Posted: 2014-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Drug Group	Osteoform	Osteoform
Control group	SHELCAL	SHELCAL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (5)

CARE Hospitals; 🇮🇳 Hyderabaad, Andhra Pradesh, India

MS Ramaiah Medical College; 🇮🇳 Bangalore, Karnataka, India

P.D. Hinduja Hospital and Medical Research Center; 🇮🇳 Mumbai, Maharastra, India

Apollo Hospitals; 🇮🇳 Chennai, Tamil Nadu, India

Medwin Hospital; 🇮🇳 Hyderabaad, Andhra Pradesh, India