Phase 4
Completed N=12
Evaluation of the Effects of Teriparatide on Skeleton Images in Postmenopausal Women With Osteoporosis
Source: ClinicalTrials.gov NCT00259298 ↗Enrolled (actual)
12
Serious AEs
8.3%
Results posted
Aug 2010
Primary outcomePrimary: Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months — 33.75 percentage of change of plasma clearance — p=0.0020
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Whole Skeleton Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) to 18 Months |
33.75 | 0.0020 sig |
| SECONDARY Change in Skeletal Plasma Clearance of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities |
25.02; 3.52; 10.44; -22.20; 72.25; 128.44 | 0.0078 sig |
| SECONDARY Change in Skeletal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton, Skull, Mandible, Spine, Pelvis, Upper Extremities, and Lower Extremities |
15.63; 26.12; 5.68; 3.99; -14.54; 68.27 | 0.0098 sig |
| SECONDARY Change in Qualitative Visual Scores of Focal Uptake of 99m Technetium Methylene Diphosphonate (99m Tc-MDP) in the Whole Skeleton |
0.1; 0.1; 0; 0; 0 | 1.0 |
| SECONDARY Number of Participants With Changes in Diffuse Uptake of 99m Tc-MDP - Qualitative Visual Assessment in the Whole Skeleton |
2; 2; 6; 1; 1; 8 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00259298). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.