Postmenopausal OsteoporosisPhase 3NCT00092053
Study of Investigational Drug in Osteoporosis (MK-0217-908)
A Phase 3 study testing ibandronate in people with Postmenopausal Osteoporosis, run by Organon and Co.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis. The primary hypothesis of this study is that in postmenopausal women with osteoporosis, oral monthly ibandronate, at doses of 100 mg and 150 mg, does not achieve persistence in… Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- ibandronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- No sites listed yet
- Study dates
- Dec 2004to Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: -postmenopausal for at least 3 years, with osteoporosis at any of the following sites: [BMD > 2.0 standard deviations below young normal mean bone mass for the hip trochanter, PA lumbar spine (L1 to L4), total hip, or femoral neck based on the normative database provided by each individual manufacturer].
- willing to take study-supplied calcium and vitamin D supplement (or equivalent) and to discontinue any non-study calcium supplements for run-in period and the duration of the study. Exclusion Criteria: -pregnant or lactating, or of childbearing potential.
- participated in another therapeutic trial with an investigational compound within 30 days of randomization.
- history of hypersensitivity to any component of ibandronate tablets or has hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
- an abnormality of the esophagus which delays esophageal emptying such as stricture or achalasia.
- unable to stand or sit upright for at least 60 minutes once a month.
- current use of illicit drugs, or history of drug or alcohol abuse within the past five years.
- has any of the following: hypocalcemia; any severe malabsorption syndrome; moderate or severe hypertension which is uncontrolled; new onset angina or myocardial infarction within six months of entry into the study; evidence for impaired renal function; organ transplantation; or other significant end organ diseases (genitourinary, cardiovascular, endocrine, hepatic, psychiatric, renal, hematologic, or pulmonary).
- history of or evidence of metabolic bone disease (other than postmenopausal bone loss).
- clinical fracture in the past year.
- is receiving or has received treatment prior to randomization which might influence bone turnover.
- is receiving or expected to receive during the course of the study any medication (other than study medication) which might alter bone or calcium metabolism, including Vitamin A in excess of 10,000 IU per day or Vitamin D in excess of 5000 IU per day, calcitonin, phenytoin, heparin, or lithium.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Persistence of the Effect of Oral Monthly Ibandronate on Bone Reception in Postmenopausal Women in Osteoporosis
The purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis. The primary hypothesis of this study is that in postmenopausal women with osteoporosis, oral monthly ibandronate, at doses of 100 mg and 150 mg, does not achieve persistence in reduction of bone resorption throughout the monthly dosing interval, as demonstrated by a larger change in the serum carboxyterminal crosslinked telopeptide of Type I collagen (CTX-I) log-transformed fraction from baseline four weeks post dose compared to one week post dose, during the third month of treatment, in the participants taking ibandronate than in the participants taking placebo.
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- Placebo, ibandronate
- Keywords
- Postmenopausal, Osteoporosis
- Medical subject headings
- Osteoporosis, Postmenopausal, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
tablets
ibandronateDrug
50 mg tablets
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive 3 placebo tablets once a month, for 3 months, on the first day of each treatment cycle. Receives: Drug: Placebo |
| ibandronate 100 mg | Experimental | Participants will receive 2 ibandronate 50 mg tablets and 1 placebo tablet once a month, for 3 months, on the first day of each treatment cycle. Receives: Drug: ibandronate |
| ibandronate 150 mg | Experimental | Participants will receive 3 ibandronate 50 mg tablets once a month, for 3 months, on the first day of each treatment cycle. Receives: Drug: ibandronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum levels of CTX-I (log-transformed fraction) from Week 9 to Week 12
Measured: Baseline, Week 9, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2004 (estimated)
- Study startDec 2004
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organon and Co
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00092053
- Sponsor's protocol ID
- 0217-908
- Status last verified
- Feb 2022
- First submitted
- 21 Sep 2004
- Last updated
- 2 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Persistence of the Effect of Oral Monthly Ibandronate on Bone Reception in Postmenopausal Women in Osteoporosis
- ClinicalTrials.gov ID
- NCT00092053
- Acronym / sponsor ID
- 0217-908
- Conditions
- Postmenopausal Osteoporosis
- Keywords
- Postmenopausal, Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Organon and CoIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 24 Sep 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of an investigational drug in postmenopausal women with osteoporosis. The primary hypothesis of this study is that in postmenopausal women with osteoporosis, oral monthly ibandronate, at doses of 100 mg and 150 mg, does not achieve persistence in reduction of bone resorption throughout the monthly dosing interval, as demonstrated by a larger change in the serum carboxyterminal crosslinked telopeptide of Type I collagen (CTX-I) log-transformed fraction from baseline four weeks post dose compared to one week post dose, during the third month of treatment, in the participants taking ibandronate than in the participants taking placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive 3 placebo tablets once a month, for 3 months, on the first day of each treatment cycle. |
| ibandronate 100 mg | Experimental | Drug: ibandronateParticipants will receive 2 ibandronate 50 mg tablets and 1 placebo tablet once a month, for 3 months, on the first day of each treatment cycle. |
| ibandronate 150 mg | Experimental | Drug: ibandronateParticipants will receive 3 ibandronate 50 mg tablets once a month, for 3 months, on the first day of each treatment cycle. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Placebotablets | Drug | Placebo |
| ibandronate50 mg tablets | Drug | ibandronate 100 mg, ibandronate 150 mg |
Primary outcome
Change in serum levels of CTX-I (log-transformed fraction) from Week 9 to Week 12
Time frame: Baseline, Week 9, Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2022.
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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.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ibandronate in people with Postmenopausal Osteoporosis, run by Organon and Co.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 2 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in serum levels of CTX-I (log-transformed fraction) from Week 9 to Week 12 (time frame: Baseline, Week 9, Week 12). 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 2 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.