Phase 3
N=29
Secondary Prevention of Osteoporosis
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00421343 ↗Enrolled (actual)
29
Serious AEs
3.5%
Results posted
Jun 2011
Primary outcome: Primary: Number Adherent With the Intervention — 29 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- alendronate with cholecalciferol (Drug); calcium carbonate with cholecalciferol (Drug); Falls prevention measures (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Hebrew SeniorLife
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number Adherent With the Intervention |
29 | — |
| SECONDARY Reasons for Non-willingness to Particiapte and Non-adherence With Intervention |
— | — |
Summary
The purpose of this study is to develop and implement an evidence based protocol for the secondary prevention of osteoporotic fractures and falls, and to determine how compliance with this intervention improves muscle strength and functional status following a fracture.
Eligibility Criteria
Inclusion Criteria
- Admitted to rehab unit with the primary or secondary diagnosis of fracture
- English speaking
- Cognitively able to provide consent or health care proxy available and willing to provide consent
- Willing to cooperate
Exclusion Criteria
- Pathologic or periprosthetic fractures
- Creatinine clearance less than 15ml/minute
- Severe hypocalcemia
- Esophageal stricture or achalasia
- Taking other treatment for osteoporosis besides calcium or vitamin D in the past 6-months
- History of kidney stones in the past 6-months
Data sourced from ClinicalTrials.gov (NCT00421343). 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.