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

Study Assessing the Efficacy, Safety, and Pharmacokinetics of 75 and 100 mg Once-a-month Delayed-release Risedronate Formulations Compared to 150 mg Once-a-month Immediate-release Risedronate for 3 Months in Postmenopausal Women Age 45-80

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.

Study Overview

• Status: Completed
• Conditions: Postmenopausal Osteoporosis
• Intervention / Treatment: Drug: 150 mg; Drug: 75 mg; Drug: 100 mg

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Florida
    • Daytona, Florida, United States, 32117
      • Research Site
    • Ft. Myers, Florida, United States, 33901
      • Research Site
  • Hawaii
    • Honolulu, Hawaii, United States, 96821
      • Research Site
  • Indiana
    • Evansville, Indiana, United States, 47711
      • Research Site
  • Texas
    • Austin, Texas, United States, 78727
      • Research Site
    • Dallas, Texas, United States, 75247
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 150 mg; 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.	Drug: 150 mg; 150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.
Experimental: 75 mg; 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	Drug: 75 mg; 75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
Experimental: 100 mg; 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast	Drug: 100 mg; 100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.	Month 4

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Warner Chilcott

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): October 1, 2009

Study Registration Dates

• First Submitted: June 10, 2009
• First Submitted That Met QC Criteria: June 10, 2009
• First Posted (Estimate): June 11, 2009

Study Record Updates

• Last Update Posted (Estimate): June 29, 2015
• Last Update Submitted That Met QC Criteria: June 1, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Musculoskeletal Diseases; Bone Diseases; Bone Diseases, Metabolic; Osteoporosis; Osteoporosis, Postmenopausal
• Other Study ID Numbers: 2009003