CompletedPhase 4

Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis

United Kingdom12 participantsStarted 2005-11

Plain-language summary

The purpose of this study is to evaluate the effects of teriparatide on skeleton images in postmenopausal women with osteoporosis. Teriparatide is a bone formation agent that stimulates the production of new bone in the skeleton. This process of bone formation can be studied using a technique commonly referred to as a bone scan or nuclear scintigraphy. This trial will test whether bone scans will identify areas of the skeleton that are forming new bone during teriparatide therapy. It also will study what these areas look like after therapy is stopped.

Who can participate

Age range50 Years – 85 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ambulatory with osteoporosis * Hip or spine bone mineral density (BMD) measurement more than 2.5 standard deviations below the average bone mass of young healthy women or more than 2.0 standard deviations in women who have a history of a vertebral or nonvertebral fragility fracture. Exclusion Criteria: * Diseases of bone other than osteoporosis * Treatment with estrogens in the 3 months prior to enrollment or for more than 2 months in the past year * Treatment with oral bisphosphonates in the 3 months prior to enrollment or for more than 2 months in the past year; treatment with intravenous bisphosphonates in the 12 months prior to enrollment * Increased risk for the development of osteosarcoma

What they're measuring

Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months

Timeframe: baseline, 18 months

Trial details

NCT IDNCT00259298

SponsorEli Lilly and Company

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-07

Results submitted2010-07-14