N/A
Completed N=142
Predictive Value of Bone Turnover Markers During Discontinuation With Alendronate
Source: ClinicalTrials.gov NCT03051620 ↗Enrolled (actual)
142
Serious AEs
4.9%
Results posted
Mar 2021
Primary outcomePrimary: If Carboxy-terminal Collagen Crosslinks (CTX) Three and Six Months After Stopping Alendronate Predicted TH BMD (Total Hip BMD) Loss Above the Least Significant Change at Month 12 at the Individual Level. — 49; 64; 1.14 percentage change
Summary
The study is a cohort study comprising 136 patients with osteoporosis stopping treatment with alendronate. The study will contribute with new knowledge about biochemical markers of bone turnover as predictors of bone loss after stopping treatment with alendronate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY If Carboxy-terminal Collagen Crosslinks (CTX) Three and Six Months After Stopping Alendronate Predicted TH BMD (Total Hip BMD) Loss Above the Least Significant Change at Month 12 at the Individual Level. |
49; 64; 1.14 | — |
| SECONDARY Percent Change in Bone Turnover Markers Measured Three and Six Months After Stopping Alendronate Treatment and BMD After One and Two Years |
36; 54; -1.14; -2.65 | — |
| SECONDARY Number of Participants in Which CTX Increased Above the Least Significant Change |
85 | — |
| SECONDARY The Number of Participants Who Lost BMD Beyond the Least Significant Change (LSC) at the Lumbar Spine and Total Hip. |
21; 26 | — |
| SECONDARY If Baseline Bone Turnover Markers at the Time of Alendronate Discontinuation Predict Changes in BMD After One and Two Years. |
-1.14; -2.65 | — |
Eligibility Criteria
Inclusion Criteria
- Postmenopausal women (postmenopausal for at least two years)
- Men above 50 years
- Treatment for at least five years with alendronate
- BMD T-score total hip > -2.5
- BMD T-score lumbar spine (L1-L4) > -4
Exclusion Criteria
- Any low-energy fracture within the previous five years during alendronate treatment (not including fingers, toes, or skull)
- Low-energy vertebral fracture at any time
- Low-energy hip fracture at any time
- Ongoing treatment with glucocorticoids
- Metabolic bone disease
- Hormone replacement therapy
- Cancer
- Other conditions affecting bone metabolism
Data sourced from ClinicalTrials.gov (NCT03051620). 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.