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

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.

Study Overview

• Status: Completed
• Conditions: Osteoporosis
• Intervention / Treatment: Drug: Osteoform; Drug: SHELCAL

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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Phase 3

Contacts and Locations

Study Locations

• India
  • Andhra Pradesh
    • Hyderabaad, Andhra Pradesh, India
      • Apollo Hospitals
    • Hyderabaad, Andhra Pradesh, India
      • Care Hospitals
    • Hyderabaad, Andhra Pradesh, India
      • Medwin Hospital
  • Karnataka
    • Bangalore, Karnataka, India
      • MS Ramaiah Medical College
  • Maharastra
    • Mumbai, Maharastra, India
      • P.D. Hinduja Hospital and Medical Research Center
  • Tamil Nadu
    • Chennai, Tamil Nadu, India
      • Apollo Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Virchow Group
• Investigators: Principal Investigator: Dr. Bipin Kumar Sethi, MD, DM, CARE Hospitals, Hyderabad, AP, India; Principal Investigator: Dr. Manoj Chadha, MD, DM, P.D. Hinduja Hospital and Medical Research Centre, Mumbai, India; Principal Investigator: Dr. K.Prasanna Kumar, MD, DM, M.S. Ramaiah Medical College, Bangalore, India; Principal Investigator: Dr. K.D. Modi, MD, DM, Medwin Hospital, Hyderabad, AP, India; Principal Investigator: Dr. Rabinderanath Mehrotra, MD, DM, Apollo Hospitals, Hyderabad, AP, India; Principal Investigator: Dr. Usha Sriram, MD, DM, Apollo Hospitals, Chennai, India

Publications and helpful links

General Publications

• Sethi BK, Chadha M, Modi KD, Kumar KM, Mehrotra R, Sriram U. Efficacy of teriparatide in increasing bone mineral density in postmenopausal women with osteoporosis--an Indian experience. J Assoc Physicians India. 2008 Jun;56:418-24.

Study record dates

Study Major Dates

• Study Start: December 1, 2005
• Primary Completion (Actual): December 1, 2006
• Study Completion (Actual): July 1, 2007

Study Registration Dates

• First Submitted: July 11, 2007
• First Submitted That Met QC Criteria: July 11, 2007
• First Posted (Estimate): July 12, 2007

Study Record Updates

• Last Update Posted (Estimate): December 16, 2014
• Last Update Submitted That Met QC Criteria: December 15, 2014
• Last Verified: July 1, 2007

More Information

Terms related to this study

• Keywords: Osteoporosis; rhPTH(1-34)
• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Physiological Effects of Drugs; Micronutrients; Vitamins; Bone Density Conservation Agents; Vitamin D
• Other Study ID Numbers: VB006/05