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

NCT00918749 | Completed Phase 2 Results

• 1 other identifier: 2009003
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 6

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.

Conditions

Postmenopausal Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

  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

  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

  4 months

Study Arms (3)

150 mg

ACTIVE COMPARATOR

150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.

Drug: 150 mg

75 mg

EXPERIMENTAL

75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast

Drug: 75 mg

100 mg

EXPERIMENTAL

100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast

Drug: 100 mg

Interventions

150 mg DRUG

150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.

150 mg

75 mg DRUG

75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

75 mg

100 mg DRUG

100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

100 mg

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Warner Chilcott: lead

Study Sites (6)

Research Site

Daytona Beach, Florida, 32117, United States

Location

Research Site

Fort Myers, Florida, 33901, United States

Location

Research Site

Honolulu, Hawaii, 96821, United States

Location

Research Site

Evansville, Indiana, 47711, United States

Location

Research Site

Austin, Texas, 78727, United States

Location

Research Site

Dallas, Texas, 75247, United States

Location

MeSH Terms

Conditions

Osteoporosis, Postmenopausal

Condition Hierarchy (Ancestors)

Osteoporosis; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Grexan Wulff, Manager, Regulatory Affairs
• Organization: Warner Chilcott

gwulff@wcrx.com

973-442-3376

Study Officials

• Chantell Wilson, PhD

  Procter and Gamble

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2009
• First Posted: June 11, 2009
• Study Start: May 1, 2009
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: June 29, 2015
• Results First Posted: March 24, 2011

Record last verified: 2015-06

Locations

US (6)