Phase 4
Completed N=35
A Study Using Imaging Technology to Measure Changes in Bone Structure After Treatment With Teriparatide
Osteoporosis, Postmenopausal
Source: ClinicalTrials.gov NCT00557310 ↗
Enrolled (actual)
35
Serious AEs
14.3%
Results posted
Nov 2011
Primary outcomePrimary: Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint — 4.53 percent (%) change of ratio — p=0.363
Summary
The purpose of this study is to use imaging technologies to demonstrate the effects of teriparatide on bone structure following 18 to 24 months of therapy in postmenopausal women with osteoporosis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 18 Endpoint |
4.53 | 0.363 |
| SECONDARY Percent Change From Baseline in Surface-to-Curve Ratio (SCR) in the Distal Radius at Month 24 Endpoint |
1.44 | 0.837 |
| SECONDARY Percent Change From Baseline in Cortical Thickness (CT) in the Distal Radius at Month 18 and 24 Endpoint |
-0.61; -0.22 | 0.816 |
| SECONDARY Percent Change From Baseline in Topological Erosion Index (TEI) in the Distal Radius at Month 18 and 24 Endpoint |
3.36; 8.46 | 0.324 |
| SECONDARY Percent Change From Baseline in Bone Volume (BV)/Total Volume (TV) Ratio in the Distal Radius at Month 18 and 24 Endpoint |
0.36; -3.14 | 0.847 |
| SECONDARY Percent Change From Baseline in Surface-to-Curve Ratio (SCR) at Month 3, 6, 12, 18 and 24 Endpoint |
-3.38; 0.43; 2.36; 4.53; 1.44 | 0.335 |
| SECONDARY Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Lumbar Spine at Month 18 Endpoint |
10.05 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Volumetric Bone Mineral Density (BMD) of Hip at Month 18 Endpoint |
2.22 | 0.021 sig |
| SECONDARY Percent Change From Baseline in the Estimate of Bone Strength of Lumbar Spine at Month 18 Endpoint |
17.43 | <0.001 sig |
| SECONDARY Percent Change From Baseline in the Estimate of Bone Strength of Hip at Month 18 Endpoint |
2.54 | 0.045 sig |
| SECONDARY Percent Change From Baseline in Areal BMD at the Lumbar Spine at Month 18 and 24 Endpoint |
7.215; 8.702 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Areal BMD at the Femoral Neck at Month 18 and 24 Endpoint |
2.792; 2.762 | 0.011 sig |
| SECONDARY Percent Change From Baseline in Areal BMD Responses at Total Hip at Month 18 and 24 Endpoint |
0.292; 1.482 | 0.700 |
| SECONDARY Percent Change From Baseline in Areal BMD at ⅓ Distal Radius at Month 18 and 24 Endpoint |
-2.068; -2.733 | 0.013 sig |
| SECONDARY Percent Change From Baseline in Areal BMD at Ultra-Distal Radius at Month 18 and 24 Endpoint |
-1.891; 0.776 | 0.106 |
| SECONDARY Percent Change From Baseline in Serum Procollagen Type I N-Terminal Propeptide (PINP) at Month 3, 6 and 24 Endpoint |
145.35; 238.04; 118.91 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Serum Carboxyterminal Cross-Linking Telopeptide of Type I Collagen (CTX) at Month 3, 6 and 24 Endpoint |
63.53; 102.56; 48.28 | 0.012 sig |
Eligibility Criteria
Inclusion Criteria
- postmenopausal (after the "change of life") women with osteoporosis
- between the ages of 45-85
- have low bone mass as determined by a bone density test
- have at least one prior atraumatic vertebral or nonvertebral fracture(with a T-score of -2.0 or lower at the lumbar spine, total hip, or femoral neck) or, no prior fracture (with a T-score of -3.0 or lower at these same sites)
- could have taken up to 5 years total of certain oral osteoporosis medications such as alendronate, risedronate, or ibandronate
Exclusion Criteria
- have conditions that would affect the bone in the region of the wrist or have had a previous fracture of either wrist which might affect results of study
- have a metal implant or have had a hip replacement in either hip which might affect results of study
- have an increased risk of osteosarcoma; includes Paget's disease of bone, a previous bone tumor, or x-ray treatment to the skeleton
- currently have active or suspected diseases that affect the bone, other than osteoporosis
- have abnormal levels of calcium, parathyroid hormone in blood, or other laboratory values
Data sourced from ClinicalTrials.gov (NCT00557310). 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.