NCT01293292

Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action

Teriparatide (Forsteo) Treatment in Postmenopausal Women: Mechanism of Action. A Two-year Open-label Single-arm Study of Teriparatide in Secondary Care

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 84 Years
• Healthy volunteers: Not accepted

Summary

Previously the approach to treatment of osteoporosis has been to use medications which prevent excessive resorption of bone. More recently medications that build up new bone, i.e. anabolic treatments, have been, and are being, developed. The investigators would like to develop a strategy for evaluating the effectiveness of anabolic therapies by studying a currently available therapy (teriparatide). This strategy could then be used to assess new anabolic treatments as they are developed for use in humans. The aims of this study are 1) to fully describe the changes in bone turnover in response to teriparatide by biochemical marker type and by time; 2) to fully describe the changes in bone mineral density (BMD) in response to teriparatide by site, bone compartment and time. If this study is able to identify an early response to treatment, then this will help speed up drug development in this area, by allowing the identification of promising new anabolic drugs and enabling us to understand their mechanism of action. This will benefit the investigators patients as the investigators will have a better understanding of how these drugs work.

Conditions

• Osteoporosis

Interventions

Type	Name	Description
DRUG	Teriparatide	Teriparatide (Forsteo) 20 mcg subcutaneous injection once daily. Duration 104 weeks.

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2011-02-10
• Last updated: 2017-05-08

Locations

1 site across 1 country: United Kingdom