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

Primary Purpose

Postmenopausal Osteoporosis

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

150 mg

75 mg

100 mg

About this trial

This is an interventional treatment trial for Postmenopausal Osteoporosis

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Research Site
Research Site
Research Site
Research Site
Research Site
Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Arm Label

150 mg

75 mg

100 mg

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population

Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, 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

Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA.

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

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

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

Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population

ITT Population

Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population

ITT Population

Full Information

NCT ID

NCT00918749

First Posted

June 10, 2009

Last Updated

June 1, 2015

Sponsor

Warner Chilcott

1. Study Identification

Unique Protocol Identification Number

NCT00918749

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

May 2009 (undefined)

Primary Completion Date

October 2009 (Actual)

Study Completion Date

October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Warner Chilcott

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postmenopausal Osteoporosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

205 (Actual)

8. Arms, Groups, and Interventions

Arm Title

150 mg

Arm Type

Active Comparator

Arm Description

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

Arm Title

75 mg

Arm Type

Experimental

Arm Description

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

Arm Title

100 mg

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

150 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

75 mg

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

100 mg

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.

Time Frame

Month 4

Secondary Outcome Measure Information:

Title

Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population

Time Frame

2 months

Title

Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population

Time Frame

3 months

Title

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

Description

Urine NTX Bone turnover marker collected after 8 hour fast, 2nd voided urine between 6-9 am assayed by ELISA.

Time Frame

2 months

Title

Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population

Description

ITT Population

Time Frame

3 months

Title

Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population

Description

ITT Population

Time Frame

4 months

Title

Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population

Description

ITT Population

Time Frame

2 months

Title

Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population

Description

ITT Population

Time Frame

3 months

Title

Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population

Description

ITT Population

Time Frame

4 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chantell Wilson, PhD

Organizational Affiliation

Procter and Gamble

Official's Role

Study Director

Facility Information:

Facility Name

Research Site

City

Daytona

State/Province

Florida

ZIP/Postal Code

32117

Country

United States

Facility Name

Research Site

City

Ft. Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Facility Name

Research Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96821

Country

United States

Facility Name

Research Site

City

Evansville

State/Province

Indiana

ZIP/Postal Code

47711

Country

United States

Facility Name

Research Site

City

Austin

State/Province

Texas

ZIP/Postal Code

78727

Country

United States

Facility Name

Research Site

City

Dallas

State/Province

Texas

ZIP/Postal Code

75247

Country

United States

12. IPD Sharing Statement

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

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