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

Evaluation of Safety and Efficacy of Teriparatide in Addition to Calcium And Vitamin D Supplementation in Comparison to Calcium and Vitamin D Supplementation Alone, in Increasing The Bone Mineral Density in Post-menopausal Women with Osteoporosis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2010/091/000242

Enrollment

Registered

2010-04-13

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

None listed

Interventions

Intervention1: Teriparatide [recombinant human parathyroid hormone (rPTH[1-34]) analogue]: 20 Microgram injection by sc route, once daily for 12 months. Control Intervention1: Oral calcium supplementa

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women with at least 3 years of post menopause, aged between 48 and 75 years. 2. Osteoporosis indicated by lumbar spine or femoral neck or total hip T score &#8804; -2.5 on Dual energy X-ray absorptiometry (DEXA). 3. Normal thyroid and parathyroid function as indicated by baseline T3, T4 and TSH.4. Willingness to provide an informed and written consent.

Exclusion criteria

Exclusion criteria: 1. Women with vertebral abnormalities at L1 to L4 that may interfere with the vertebral assessment by DEXA. 2. Vitamin D deficiency as indicated by serum levels of 25-OH vitamin D < 20 ng/ml. 3. Patients with serum PTH > 65 pg/ml. 4. Patients with known hypersensitivity to Teriparatide, Vitamin D or Calcium supplements. 5. Patients with hypercalciuria or hypercalcemia. 6. Patients with hyperuremia or known history of gout and other diseases releated to uric acid accumulation. 7. Patients with a history of active or treated tuberculosis. 8. Patients with a history of significant liver disease, kidney disease, gastrointestinal disease or cancer. 9. 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. 10. Patients with clinically significant unstable medical disorders, life threatening disease, or current malignancies. 11. Patients with a BMI of < 18.5 kg/m2. 12 Patients on any of the following medications: Systemic or inhaled corticosteroids, Anticoagulants, Anticonvulsants. 13. Patients who are unwilling or unable to comply with the requirements of the protocol.

Design outcomes

Primary

Measure	Time frame
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.Timepoint: At the end of study drug treatment (360 days from start of treatment)	—

Secondary

Measure	Time frame
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.Timepoint: At the end of study drug treatment (360 days from start of treatment)	—

Countries

India

Contacts

Public ContactMr. Pawan Bhusari

vasant.joshi@usv.co.in+91-22-25564048

Outcome results