A clinical trial with Teriparatide: a recombinant human parathyroid hormone) and Calcium and Vitamin D Supplementation in Post-menopausal Women with Osteoporosis.

Phase 3

• Conditions: Osteoporosis

• Registration Number: CTRI/2010/091/000242
• Lead Sponsor: USV Ltd B S D Marg, Govandi,Mumbai 400 088Phone: (022) 2556 4048; Fax : (022) 2558 4025

Brief Summary

This proposed study is a randomized, open label, prospective, controlled, multicentric, between group comparison trial, eligible and consenting post-menopausal patients will be enrolled and randomized into two groups - Group I or Group II. Group I and Group II, will receive oral calcium supplementation of 1000 mg of elemental calcium and Vitamin D 500 IU per day, in two divided doses. In addition, Group I will receive Teriparatide sc injection 20 µg per day. All the patients will be assessed for primary endpoint, viz., increase in bone mineral density at Lumbar spine L 1 to L 4 from baseline, and secondary endpoints such as increase in bone mineral density at femoral neck and total hip regions, change from baseline in biomarkers of bone formation and bone resorption and occurrence of adverse events. This study will be conducted in approximately 5 -6 centers in India to recruit approximately 80 patients.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

• Women with at least 3 years of post menopause, aged between 48 and 75 years.
• Osteoporosis indicated by lumbar spine or femoral neck or total hip T score ≤ -2.5 on Dual energy X-ray absorptiometry (DEXA).
• Normal thyroid and parathyroid function as indicated by baseline T3, T4 and TSH.4. Willingness to provide an informed and written consent.

Exclusion Criteria

• Women with vertebral abnormalities at L1 to L4 that may interfere with the vertebral assessment by DEXA.
• Vitamin D deficiency as indicated by serum levels of 25-OH vitamin D < 20 ng/ml.
• Patients with serum PTH > 65 pg/ml.
• Patients with known hypersensitivity to Teriparatide, Vitamin D or Calcium supplements.
• Patients with hypercalciuria or hypercalcemia.
• Patients with hyperuremia or known history of gout and other diseases releated to uric acid accumulation.
• Patients with a history of active or treated tuberculosis.
• Patients with a history of significant liver disease, kidney disease, gastrointestinal disease or cancer.
• Patients receiving concomitant medications such as oestrogen or oestrogen related compounds, bisphosphonates, fluorides or calcitonin within the previous 6 months that might have influenced bone mineralization.
• Patients with clinically significant unstable medical disorders, life threatening disease, or current malignancies.
• 12 Patients on any of the following medications: Systemic or inhaled corticosteroids, Anticoagulants, Anticonvulsants.
• Patients who are unwilling or unable to comply with the requirements of the protocol.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
At the end of study drug treatment (360 days from start of treatment) in Groups I and II: Increase in Bone Mineral density (BMD) from baseline at Lumbar spine L 1 to L 4.	At the end of study drug treatment (360 days from start of treatment)

Secondary Outcome Measures

Name	Time	Method
At the end of study drug treatment (360 days from start of treatment) in Groups I and II :Change in Bone Mineral density (BMD) from baseline at femoral neck and total hip regions. Change from baseline in biomarkers of bone formation and bone resorption. Occurrence of adverse events.	At the end of study drug treatment (360 days from start of treatment)

Trial Locations

Locations (5)

Associates in Clinical Endocrinology Education and Research (ACEER), 7/12, 15th Cross street, Sastri Nagar, Adyar, Chennai ? 600020; 🇮🇳 Chennai, TAMIL NADU, India

Department of Endocrinology, Bharti Research Institute of Diabetes and Endocrinology , Bharti Hospital, Wagir Chand Colony, Kunj Pura Road Model Town, Near - Civil Line, Karnal Haryana; 🇮🇳 Karnal, HARYANA, India

Excel Centre, Maya Ville, Barthakur Mill Road, Ulubari, Guwahati ? 781007, Assam; 🇮🇳 India

Jehangir Clinical Development Center Pvt Ltd, 32 Sassoon Road, Pune- 411005; 🇮🇳 India

Jnana Sanjeevini Medical Center; 🇮🇳 Bangalore, KARNATAKA, India

Associates in Clinical Endocrinology Education and Research (ACEER), 7/12, 15th Cross street, Sastri Nagar, Adyar, Chennai ? 600020

🇮🇳Chennai, TAMIL NADU, India

Dr. Usha Sriram

Principal investigator

044-24460760

drushasriram@gmail.com