Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women

Phase 2

Completed

• Conditions: Postmenopausal Osteoporosis
• Interventions: Drug: 150 mg; Drug: 100 mg; Drug: 75 mg

• Registration Number: NCT00918749
• Lead Sponsor: Warner Chilcott

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-06-10
• Study First Submitted QC: 2009-06-10
• Study First Posted: 2009-06-11
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Results First Submitted: 2011-02-23
• Results First Submitted QC: 2011-02-23
• Results First Posted: 2011-03-24
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-01
• Last Update Posted: 2015-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 205

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
150 mg	150 mg	150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
100 mg	100 mg	100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
75 mg	75 mg	75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast

Primary Outcome Measures

Name	Time	Method
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	Month 4	Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.

Secondary Outcome Measures

Name	Time	Method
Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population	4 months	ITT Population
Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population	4 months	ITT Population
Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population	3 months	ITT Population
Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population	3 months	ITT Population
Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population	2 months
Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population	3 months
Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population	2 months	ITT Population
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	2 months	Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA.

Trial Locations

Locations (1)

Research Site; 🇺🇸 Dallas, Texas, United States