CompletedNCT00918749Updated Jun 29, 2015Results posted

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

A Phase 2 interventional study of 150 mg and 75 mg in Postmenopausal Osteoporosis, sponsored by Warner Chilcott. Completed at 6 sites in United States. Open to female participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-06-29.

Sponsored by Warner Chilcott · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 205
Allocation: Randomized
Ages: 45 Years to 80 Years
Sex: Female

Study 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 studied

Postmenopausal Osteoporosis

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In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's enrollment of 205 is above the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

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Lead sponsor

Warner Chilcott is the lead sponsor of 57 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years to 80 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

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

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 design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Investigator, Outcomes assessor)
Enrollment: 205 participants (actual)

Study arms

Active comparator
150 mg
150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
Drug: 150 mg
Experimental
75 mg
75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Drug: 75 mg
Experimental
100 mg
100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
Drug: 100 mg

Interventions

Drug150 mg
150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.
Drug75 mg
75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
Drug100 mg
100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast

What researchers measure

Primary outcomes

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.
Time frame: Month 4

Secondary outcomes

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
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
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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 2 months
Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population
ITT Population
Time frame: 3 months
Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population
ITT Population
Time frame: 4 months

Results

Posted Mar 24, 2011

Participant flow

Screening began 27 May 2009

Participant flow — Overall Study
Milestone	150 mg	75 mg	100 mg
Started	70	66	69
Itt (intent to treat) population	69	66	69
Completed	63	63	62
Not completed	7	3	7
Withdrew: Adverse event	1	0	1
Withdrew: Lost to follow-up	0	0	1
Withdrew: Withdrawal by subject	5	3	5
Withdrew: No study medication taken	1	0	0

Outcome measures

PrimaryPercentage 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.

Time frame:: Month 4
Reported as:: Least squares mean · Percent Change from Baseline

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
Percent Change from Baseline	150 mg	75 mg	100 mg
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	-41.235 ± 2.995	-44.832 ± 3.012	-53.432 ± 3.025

Statistical analysis

150 mg vs 75 mg · ANOVA · p = 0.3946 · Ls mean difference: -3.598 · 90% CI -10.568 to 3.372Fixed effects for treatment and center.
150 mg vs 100 mg · ANOVA · p = 0.0045 · Ls mean difference: -12.197 · 90% CI -19.208 to -5.185Fixed effects for treatment and center.

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

Time frame:: 2 months
Reported as:: Least squares mean · Percent Change from Baseline

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	150 mg	75 mg	100 mg
Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population	-38.407 ± 3.504	-33.641 ± 3.538	-38.625 ± 3.547

Statistical analysis

150 mg vs 75 mg · ANOVA · p = 0.3372 · Ls mean difference: 4.765 · 90% CI -3.421 to 12.952Fixed effects for treatment and center.
150 mg vs 100 mg · ANOVA · p = 0.9650 · Ls mean difference: -0.218 · 90% CI -8.427 to 7.991Fixed effects for treatment and center.

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

Time frame:: 3 months
Reported as:: Least squares mean · Percent Change from Baseline

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	150 mg	75 mg	100 mg
Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population	-35.591 ± 3.045	-35.203 ± 3.034	-46.379 ± 3.077

Statistical analysis

150 mg vs 75 mg · ANOVA · p = 0.9276 · Ls mean difference: 0.388 · 90% CI -6.670 to 7.447Fixed effects for treatment and center.
150 mg vs 100 mg · ANOVA · p = 0.0133 · Ls mean difference: -10.787 · 90% CI -17.917 to -3.657Fixed effects for treatment and center.

SecondaryPercent 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.

Time frame:: 2 months
Reported as:: Least squares mean · Percent Change from Baseline

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
Percent Change from Baseline	150 mg	75 mg	100 mg
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	-15.365 ± 6.567	-0.837 ± 6.631	-1.150 ± 6.689

Statistical analysis

150 mg vs 75 mg · ANOVA · p = 0.1192 · Ls mean difference: 14.528 · 90% CI -0.813 to 29.868Fixed effects for treatment and center.
150 mg vs 100 mg · ANOVA · p = 0.1298 · Ls mean difference: 14.215 · 90% CI -1.230 to 29.659Fixed effects for treatment and center.

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

ITT Population

Time frame:: 3 months
Reported as:: Least squares mean · Percent Change from Baseline

Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population
Percent Change from Baseline	150 mg	75 mg	100 mg
Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population	-21.673 ± 4.351	-20.555 ± 4.326	-29.066 ± 4.356

Statistical analysis

150 mg vs 75 mg · ANOVA · p = 0.8546 · Ls mean difference: 1.119 · 90% CI -8.956 to 11.193Fixed effects for treatment and center.
150 mg vs 100 mg · ANOVA · p = 0.2291 · Ls mean difference: -7.393 · 90% CI -17.522 to 2.737Fixed effects for treatment and center.

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

ITT Population

Time frame:: 4 months
Reported as:: Least squares mean · Percent Change from Baseline

Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population
Percent Change from Baseline	150 mg	75 mg	100 mg
Percent Change From Baseline Urine NTX Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population	-13.447 ± 6.427	-7.942 ± 6.464	-14.360 ± 6.492

Statistical analysis

150 mg vs 75 mg · ANOVA · p = 0.5436 · Ls mean difference: 5.505 · 90% CI -9.452 to 20.462Fixed effects for treatment and center.
150 mg vs 100 mg · ANOVA · p = 0.9201 · Ls mean difference: -0.914 · 90% CI -15.959 to 14.132Fixed effects for treatment and center.

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

ITT Population

Time frame:: 2 months
Reported as:: Least squares mean · Percent Change from Baseline

Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population
Percent Change from Baseline	150 mg	75 mg	100 mg
Serum Bone Specific Alkaline Phosphatase (BAP) Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 2, ITT Population	-5.457 ± 2.867	-2.349 ± 2.895	-0.615 ± 2.902

Statistical analysis

150 mg vs 75 mg · ANOVA · p = 0.4440 · Ls mean difference: 3.108 · 90% CI -3.590 to 9.807Fixed effects for treatment and center.
150 mg vs 100 mg · ANOVA · p = 0.2349 · Ls mean difference: 4.842 · 90% CI -1.874 to 11.559Fixed effects for treatment and center.

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

ITT Population

Time frame:: 3 months
Reported as:: Least squares mean · Percent Change from Baseline

Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population
Percent Change from Baseline	150 mg	75 mg	100 mg
Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population	-17.797 ± 3.087	-12.831 ± 3.075	-12.872 ± 3.119

Statistical analysis

150 mg vs 75 mg · ANOVA · p = 0.2527 · Ls mean difference: 4.966 · 90% CI -2.189 to 12.120Fixed effects for treatment and center.
100 mg · ANOVA · p = 0.2613 · Ls mean difference: 4.926 · 90% CI -2.301 to 12.153Fixed effects for treatment and center.

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

ITT Population

Time frame:: 4 months
Reported as:: Least squares mean · Percent Change from Baseline

Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population
Percent Change from Baseline	150 mg	75 mg	100 mg
Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population	-20.885 ± 2.956	-19.616 ± 2.973	-23.710 ± 2.986

Statistical analysis

150 mg vs 75 mg · ANOVA · p = 0.7606 · Ls mean difference: 1.269 · 90% CI -5.609 to 8.148Fixed effects for treatment and center.
100 mg · ANOVA · p = 0.5006 · Ls mean difference: -2.825 · 90% CI -9.744 to 4.095Fixed effects for treatment and center.

Adverse events

Collected over 27 May 2009 thru 23 October 2009, 5 months. Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
150 mg	—	0/69 (0%)	50/69 (72.5%)
75 mg	—	0/66 (0%)	43/66 (65.2%)
100 mg	—	0/69 (0%)	49/69 (71%)

Most frequent other events

Showing 10 of 41

Most frequent other events
Event	150 mg	75 mg	100 mg
HeadacheNervous system disorders	20/69	15/66	18/69
Abdominal PainGastrointestinal disorders	5/69	16/66	14/69
DiarrhoeaGastrointestinal disorders	11/69	15/66	15/69
MyalgiaMusculoskeletal and connective tissue disorders	3/69	7/66	10/69
ConstipationGastrointestinal disorders	4/69	9/66	5/69
NauseaGastrointestinal disorders	6/69	6/66	9/69
Back PainMusculoskeletal and connective tissue disorders	8/69	6/66	4/69
PainGeneral disorders	6/69	7/66	5/69
ArthralgiaMusculoskeletal and connective tissue disorders	6/69	2/66	7/69
VomitingGastrointestinal disorders	3/69	6/66	6/69

Baseline characteristics

Age, Continuous
Age, Continuous(years)	150 mg	75 mg	100 mg	Total
Mean	58.3 ± 7.2	58.2 ± 7.2	57.5 ± 7.0	58.0 ± 7.1

Age, Customized
Age, Customized(participants)	150 mg	75 mg	100 mg	Total
< 65 years	57	53	55	165
65 years thru <75 years	10	12	13	35
>= 75 years	2	1	1	4

Sex: Female, Male
Sex: Female, Male(Participants)	150 mg	75 mg	100 mg	Total
Female	70	66	69	205
Male	0	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	150 mg	75 mg	100 mg	Total
Asian (Oriental)	7	6	3	16
Black	0	4	3	7
Caucasian	60	53	61	174
Multi-Racial	1	3	1	5
Hawaiian/Pacific Islander	1	0	1	2

Region of Enrollment
Region of Enrollment(participants)	150 mg	75 mg	100 mg	Total
United States	70	66	69	205

Study locations

6 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00918749
Lead sponsor: Warner Chilcott
Responsible party: Sponsor
First posted: Jun 11, 2009
Start date: May 2009
Primary completion: Oct 2009
Completion: Oct 2009
Results posted: Mar 24, 2011
Last update: Jun 29, 2015

Study contacts

Chantell Wilson, PhD

study director · Procter and Gamble

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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

Study summary

Conditions studied

Browse trials for

In context

Osteoporosis

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

Updates

Registry details

Key details

Study contacts

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria