Postmenopausal OsteoporosisPhase 2NCT00918749
Delayed Release (DR) Risedronate Compared to Immediate Release (IR) in Postmenopausal Women
A Phase 2 study testing 150 mg, 75 mg and 100 mg in people with Postmenopausal Osteoporosis, run by Warner Chilcott at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- 150 mg, 75 mg and 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 6 sitesUnited States
- Study dates
- May 2009to Oct 2009
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- 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
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Research Site
Austin, Texas, 78727
Research Site
Dallas, Texas, 75247
Research Site
Daytona Beach, Florida, 32117
Research Site
Evansville, Indiana, 47711
Research Site
Fort Myers, Florida, 33901
Research Site
Honolulu, Hawaii, 96821
About this study
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
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
- Being tested
- 150 mg, 75 mg, 100 mg
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
150 mgDrug
150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast.
75 mgDrug
75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
100 mgDrug
100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast
| Study group | Role | What they receive |
|---|---|---|
| 150 mg | Active comparator | 150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast. Receives: Drug: 150 mg |
| 75 mg | Experimental | 75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast Receives: Drug: 75 mg |
| 100 mg | Experimental | 100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast Receives: Drug: 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 2 months
Percent Change From Baseline CTX 150 mg IRBB Tablet Compared With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 2 months
Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, ITT Population
ITT Population
Measured: 3 months
Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 4, ITT Population
ITT Population
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Warner Chilcott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chantell Wilson, PhD, Study director, Procter and Gamble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918749
- Sponsor's protocol ID
- 2009003
- Status last verified
- Jun 2015
- First submitted
- 10 Jun 2009
- Last updated
- 29 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00918749
- Acronym / sponsor ID
- 2009003
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Warner ChilcottIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 11 Jun 2009 (estimated)
- Results
- Posted 24 Mar 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 150 mg | Active comparator | Drug: 150 mg150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast. |
| 75 mg | Experimental | Drug: 75 mg75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast |
| 100 mg | Experimental | Drug: 100 mg100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 150 mg150 mg immediate release (IRBB) risedronate tablet administered orally at least 30 minutes before breakfast. | Drug | 150 mg |
| 75 mg75 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast | Drug | 75 mg |
| 100 mg100 mg delayed release (DRFB) risedronate tablet administered orally immediately after ingesting breakfast | Drug | 100 mg |
Primary outcome
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
Time frame: Month 4
Fasting serum Bone turn-over marker specimen assayed by electochemiluminescence.
8 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
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
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
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
Time frame: 2 months
Serum BAP Comparing Risedronate 150 mg IRBB Tablet With 75 mg & 100 mg DRFB Tablet, Month 3, 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
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chantell Wilson, PhD study director
Procter and Gamble
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 150 mg, 75 mg and 100 mg in people with Postmenopausal Osteoporosis, run by Warner Chilcott at 6 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Month 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.