Postmenopausal Osteoporosis
Conditions
Brief summary
This study is to evaluate and compare the effects of Alendronate and Risedronate to treat women with postmenopausal osteoporosis. The primary hypothesis for this study is that in postmenopausal women with osteoporosis, treatment with oral alendronate 70 mg once weekly will produce a mean percent increase from baseline in hip trochanter bone mineral density (BMD) at 12 and 24 months which is greater than that observed with oral risedronate 35 mg once weekly.
Interventions
DRUGAlendronate
Alendronate sodium, 70 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
DRUGRisedronate 35 mg
Risendronate, 35 mg, once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
DIETARY_SUPPLEMENTElemental Calcium
Elemental calcium at least 1,000 mg daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
DIETARY_SUPPLEMENTVitamin D
Vitamin D at least 400 international units daily (diet plus supplements). Medications were taken fasting which was maintained for 30 minutes postdose.
DRUGRisendronate placebo
Risendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
DRUGAlendronate placebo
Alendronate placebo was taken once weekly for up to 24 months. Medications were taken fasting which was maintained for 30 minutes postdose.
Sponsors
Organon and Co
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women with postmenopausal osteoporosis
Exclusion criteria
* Bilateral hip replacements * Esophageal abnormalities * Metabolic bone disease (example - Vitamin D deficiency) * Medications that would affect the breakdown or build-up of bone turnover
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean percent change from baseline in hip trochanter bone mineral density (BMD) at 12 months | Baseline and 12 months |
| Mean percent change from baseline in hip trochanter BMD at 24 months | Baseline and 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in biochemical markers of bone turnover at 12 months | Baseline and 12 months |
| Change from baseline in biochemical markers of bone turnover at 24 months | Baseline and 24 months |
| Percent responders (>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 12 months | 12 months |
| Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 12 months | Baseline and 12 months |
| Number of participants who experienced one or more adverse events (AE) | Up to 24 months |
| Number of participants who discontinued study medication due to an AE | Up to 24 months |
| Percent responders ((>=0% and >=3% change from baseline in hip trochanter and lumbar spine BMD) at 24 months | 24 months |
| Mean percent change from baseline in total hip, femoral neck, posteroanterior (PA) lumbar BMD at 24 months | Baseline and 24 months |
Outcome results
None listed