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

Osteoporosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500409
• Other study ID #: VB006/05
• Status: Completed
• Phase: Phase 3
• First received: July 11, 2007
• Last updated: December 15, 2014
• Start date: December 2005
• Est. completion date: July 2007

Study information

• Verified date: July 2007
• Source: Virchow Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: July 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoporosis

Intervention

Drug:
• Osteoform
Administer Osteoform 20 µg daily subcutaneously and 1000 mg calcium and 500 IU vitamin D orally for 180 days
• SHELCAL
Administer calcium and vitamin D (1000 mg calcium and 500 IU vitamin D) orally for 180 days

Locations

Country	Name	City	State
India	MS Ramaiah Medical College	Bangalore	Karnataka
India	Apollo Hospitals	Chennai	Tamil Nadu
India	Apollo Hospitals	Hyderabaad	Andhra Pradesh
India	CARE Hospitals	Hyderabaad	Andhra Pradesh
India	Medwin Hospital	Hyderabaad	Andhra Pradesh
India	P.D. Hinduja Hospital and Medical Research Center	Mumbai	Maharastra

Sponsors (1)

Lead Sponsor	Collaborator
Virchow Group

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes