Phase 4
Completed N=343
Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)
Osteoporosis Postmenopausal
Source: ClinicalTrials.gov NCT00729651 ↗
Enrolled (actual)
343
Serious AEs
2.4%
Results posted
Apr 2010
Primary outcomePrimary: Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment — 2; 55; 134; 77 participants — p=<0.0001
Summary
To demonstrate the efficacy/safety of Fosamax Plus D
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment |
2; 55; 134; 77 | <0.0001 sig |
| SECONDARY Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment |
8.17; 29.98 | 0.0091 sig |
Eligibility Criteria
Inclusion Criteria
- Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
- Patient has been diagnosed with osteoporosis
- Patient has been postmenopausal for more than 6 months
- Patient has no contraindication to taking oral bisphosphonates
- Patient is eligible for dual energy x-ray absorptiometry in spine or hip
Exclusion Criteria
- Patients with esophageal dysfunction
- Patients who can not sit or stand at least 30 minutes
- Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial
- Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism
- Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months
Data sourced from ClinicalTrials.gov (NCT00729651). 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.