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Phase 2 Completed N=181 Randomized Double-blind Treatment

Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate

Postmenopausal Women
Source: ClinicalTrials.gov NCT00577720 ↗
Enrolled (actual)
181
Serious AEs
1.1%
Results posted
Jan 2012
Primary outcomePrimary: Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population — -43.20; -62.08; -65.11; -66.30 Percent Change

Summary

To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.

Outcome Measures

OutcomeResultp-value
PRIMARY
Percent Change in Serum CTX (Type I Collagen C-telopeptide), ITT (Intent to Treat) Population		 -43.20; -62.08; -65.11; -66.30 —
SECONDARY
Percent Change in Urine NTX/Cr (Urine Type I Collagen Cross-linked N-telopeptide Corrected for Creatinine Clearance), ITT Population		 -38.57; -46.60; -43.65; -54.27 —
SECONDARY
Percent Change in Serum BAP (Bone-specific Alkaline Phosphatase), ITT Population		 -10.99; -10.41; -20.00; -17.36 —

Eligibility Criteria

Inclusion Criteria

  • In generally good health, as determined by medical history, physical examination, and laboratory test results
  • Postmenopausal greater than 2 years, naturally or surgically based on medical history.

Exclusion Criteria

  • Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing:
  • oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day)
  • anabolic steroids
  • estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs
  • progestins
  • calcitonin
  • vitamin D supplements
  • calcitriol, calcidiol, or alfacalcidol at any dose
  • any bisphosphonate
  • fluoride
  • strontium
  • parathyroid hormone, including teriparatide
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00577720). 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.

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