Phase 2
N=205
Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women
Postmenopausal Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00918749 ↗Enrolled (actual)
205
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcome: Primary: Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population — -41.235; -44.832; -53.432 Percent Change from Baseline — p=0.3946
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 150 mg (Drug); 75 mg (Drug); 100 mg (Drug)
- Age
- Adult, Older Adult · 45+ yrs
- Sex
- Female
- Sponsor
- Warner Chilcott
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage Change From Baseline Serum Type-1 Collagen C-telopeptide (CTX) 75 mg & 100 mg DRFB Tablet Compared With 150 mg IRBB Tablet, Month 4, ITT Population |
-41.235; -44.832; -53.432 | 0.3946 |
| SECONDARY Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population |
-38.407; -33.641; -38.625 | 0.3372 |
| SECONDARY Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population |
-35.591; -35.203; -46.379 | 0.9276 |
| SECONDARY Percent Change From Baseline Urine NTX (Type-1 Collagen Cross-linked N-telopeptide) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population |
-15.365; -0.837; -1.150 | 0.1192 |
| SECONDARY Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population |
-21.673; -20.555; -29.066 | 0.8546 |
| SECONDARY Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population |
-13.447; -7.942; -14.360 | 0.5436 |
| SECONDARY Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population |
-5.457; -2.349; -0.615 | 0.4440 |
| SECONDARY Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population |
-17.797; -12.831; -12.872 | 0.2527 |
| SECONDARY Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population |
-20.885; -19.616; -23.710 | 0.7606 |
Summary
Randomized, multicenter, double-blind, double-dummy, active-controlled, parallel-design study in approximately 201 postmenopausal women. A subset of subjects (approximately 102) will also participate in a pharmacokinetic (PK) component of the study. Each subject will be randomized to 1 of 3 treatment regimens for 3 months.
Eligibility Criteria
Inclusion Criteria
- female, 45 to 80 years of age, in good general health
- postmenopausal ≥2 years, surgically or naturally
- body mass index less than or equal to 32 kg/m^2 at screening
Exclusion Criteria
- no use within 3 months prior, nor use for more than 1 month at any time within 6 months of: glucocorticoids, anabolic steroids, estrogens, selective estrogen-receptor modulators (SERMs), or estrogen-related drugs, progestins, calcitonin, vitamin D supplements (>1200 IU per day), calcitriol, calcidiol, or alfacalcidol at any dose, any bisphosphonate. fluoride (≥10 mg/day), strontium (≥50 mg/day), parathyroid hormone, investigational bone active agents.
- allergic or abnormal reactions to bisphosphonates
- history of cancer within 5 years, excluding squamous and basal cell carcinoma with 6 month remission
- positive pregnancy test
- no depot injection >10, 000 IU vitamin D in previous 9 months.
- no history of GI disease that requires medication, or history of Crohn's disease, ulcerative colitis, diverticular disease, polyps, or surgery that could have changed GI structure or motility.
- no history of frequent diarrhea or constipation that requires regular laxative use.
- no history of alcohol or durg abuse, hyperparathyroidism, cancer previous 5 years, major surgery within 1 month prior to screening, diabetes, uncontrolled hypertension, cardiovascular, hepatic, renal or GI disease.
- no active hyperthyroidism, osteomalacia, use of anticonvulsant medication, or allergic reaction to bisphosphonates
Data sourced from ClinicalTrials.gov (NCT00918749). 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.