Phase 3
N=515
A Study to Test the Effect of MK0217A on Vitamin D Inadequacy in Postmenopausal Women With Osteoporosis (0217A-262)
Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00692913 ↗Enrolled (actual)
515
Serious AEs
10.5%
Results posted
Aug 2011
Primary outcome: Primary: Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26 — 8.6; 31.0 Percentage of Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- FOSAVANCE 5600 (Alendronate Sodium (+) cholecalciferol) (Drug); Calcium Supplement 500 mg (Dietary_supplement); Referred-Care Model (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- Female
- Sponsor
- Organon and Co
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 26 |
8.6; 31.0 | <0.001 sig |
| SECONDARY Percent Change From Baseline at Week 26 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio |
-57.06; -47.36 | <0.001 sig |
| SECONDARY Percent Change From Baseline at Week 26 in Bone-Specific Alkaline Phosphatase |
-46.67; -39.60 | <0.001 sig |
| SECONDARY Percentage of Participants With Serum Levels of 25-hydroxyvitamin D Below 20 ng/mL at Week 52 |
11.3; 36.9 | <0.001 sig |
| SECONDARY Percent Change From Baseline in Lumbar Spine and Total Hip Bone Mineral Density |
4.92; 3.91; 2.22; 1.40 | 0.047 sig |
| SECONDARY Falls Per Participant |
0.51; 0.45 | 0.675 |
| SECONDARY Percent Change From Baseline at Week 52 in N-Telopeptides of Type 1 Collagen to Urine Creatinine Ratio |
-58.42; -50.07 | 0.001 sig |
| SECONDARY Percent Change From Baseline at Week 52 in Bone-Specific Alkaline Phosphatase |
-51.21; -43.13 | <0.001 sig |
Summary
A study designed to see if the study drug will increase blood levels of vitamin D, bone mineral density (BMD), improve biochemical markers of bone turnover, and reduce the number of falls as compared to women receiving standard care for osteoporosis.
Eligibility Criteria
Inclusion Criteria
- Female
- 65 years or older
- Diagnosed with osteoporosis (Bone Mineral Density (BMD) T-score <= -2.5 at spine or hip) or prior fragility fracture BMD T-score <=-1.5 in at least one of the anatomic sites including lumbar spine, total hip, and femoral neck sites
- Postmenopausal
- Low levels of vitamin D as measured 25-hydroxyvitamin D
- Has fallen at least once within the past 12 months
Exclusion Criteria
- Unable to stand or sit upright for at least 30 minutes
- Has a bone disorder other than osteoporosis
- Contraindication to the use of FOSAVANCE
Data sourced from ClinicalTrials.gov (NCT00692913). 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.