Osteoporosis, PostmenopausalPhase 4NCT00271713
Impact of Oral Ibandronate 150 mg Monthly on Structural Properties of Bone in Postmenopausal Osteoporosis (SPIMOS-3D)
A Phase 4 study testing ibandronate, calcium and vitamin D in people with Osteoporosis, Postmenopausal, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Efficacy: To investigate changes of structural bone properties in vivo using 3DpQCT ("Xtreme" CT, Scanco) in monthly oral ibandronate therapy for women with postmenopausal osteoporosis. Read more about this study
- Who is it for?
- Ages 60 to 75 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- ibandronate, calcium and vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to Sep 2007
- Phase
- Phase 4
- 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 60 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 60 and 75 years
- Menopause > 5 years
- Spine (L1 - L4) or hip BMD ≤ -2.0 and > -3.5 SD T-score measured by DXA
- Patients who, in the opinion of the investigator, are able and willing to comply with the protocol for its duration
- Written informed consent
- 3DpQCT measurable at both skeletal sites, distal tibia and radius
Who cannot join
- Spine or hip BMD ≤ -3,5 SD T-Score measured by DXA
- Vertebral fractures
- Multiple (>2) low trauma peripheral fractures
- Disease/disorder known to influence bone metabolism
- History of major upper gastro-intestinal (GI) disease
- Diagnosed malignant disease within the previous 10 years
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- Previous treatment with a bisphoshonate at any time
- Treatment with fluoride for osteoporosis (dose greater than 10 mg/day) within the last 12 months, or for more than 2 years (total duration)
- Treatment with PTH and similar agents or strontium ranelate at any time
- Treatment with other drugs affecting bone metabolism within the last 6 months
- Chronic systemic corticosteroid treatment
- Estrogens, progestins, SERMs, anabolic steroids, active vitamin D analogues/metabolites, calcitonin
- Calcineurin inhibitors (e.g. cyclosporine, tacrolimus) or methotrexate
- Total serum calcium < 2.2 mmol/l or > 2.6 mmol/l
- Vitamin D deficiency (serum 25-hydroxy vitamin D < 12 ng/ ml)
- ALT above triple upper limit of normal range
- Renal impairment (serum creatinine > 210 µmol/l)
- Contra-indications for ibandronate, calcium or vitamin D
- Employees of the Centre for Muscle and Bone Research, or their relatives
Trial locations and contacts
1 site in 1 country.
Germany1 site
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin
Berlin, 12200
About this study
Official title: Randomized Double-Blind Placebo-Controlled and Parallel Group Study to Evaluate the Impact of One Year Therapy With Monthly Oral Ibandronate 150 mg on Structural Properties of Bone in Postmenopausal Osteoporosis Without Vertebral Fractures
Efficacy:
To investigate changes of structural bone properties in vivo using 3DpQCT ("Xtreme" CT, Scanco) in monthly oral ibandronate therapy for women with postmenopausal osteoporosis.
Major structural bone parameters which determine bone strength and predict fracture risk earlier and more precisely are measurable in vivo by 3DpQCT.
Safety:
To assess the tolerability and safety of ibandronate therapy
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- ibandronate, calcium and vitamin D, placebo,calcium and vitamin D
- Keywords
- bone structure, ibandronate
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibandronate, calcium and vitamin DDrug
1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or
placebo,calcium and vitamin DDrug
2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily
| Study group | Role | What they receive |
|---|---|---|
| ibandronate | Active comparator | 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily Receives: Drug: ibandronate, calcium and vitamin D |
| 2 | Placebo comparator | placebo monthly plus 500mg calcium and 800 UI vitamin D daily Receives: Drug: placebo,calcium and vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
BV/TV and trab. Sp. measured by 3D pQCT device
Measured: Baseline and after 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2006 (estimated)
- Study startMar 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Dieter Felsenberg, Prof. Dr., Principal investigator, Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, 12200, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271713
- Sponsor's protocol ID
- ML 19472
- Status last verified
- Jan 2009
- First submitted
- 3 Jan 2006
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind Placebo-Controlled and Parallel Group Study to Evaluate the Impact of One Year Therapy With Monthly Oral Ibandronate 150 mg on Structural Properties of Bone in Postmenopausal Osteoporosis Without Vertebral Fractures
- ClinicalTrials.gov ID
- NCT00271713
- Acronym / sponsor ID
- ML 19472
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- bone structure, ibandronate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 4 Jan 2006 (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.
Efficacy:
To investigate changes of structural bone properties in vivo using 3DpQCT ("Xtreme" CT, Scanco) in monthly oral ibandronate therapy for women with postmenopausal osteoporosis.
Major structural bone parameters which determine bone strength and predict fracture risk earlier and more precisely are measurable in vivo by 3DpQCT.
Safety:
To assess the tolerability and safety of ibandronate therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ibandronate | Active comparator | Drug: ibandronate, calcium and vitamin D150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily |
| 2 | Placebo comparator | Drug: placebo,calcium and vitamin Dplacebo monthly plus 500mg calcium and 800 UI vitamin D daily |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 60 and 75 years
- Menopause > 5 years
- Spine (L1 - L4) or hip BMD ≤ -2.0 and > -3.5 SD T-score measured by DXA
- Patients who, in the opinion of the investigator, are able and willing to comply with the protocol for its duration
- Written informed consent
Key exclusion criteria (19 listed)
- Spine or hip BMD ≤ -3,5 SD T-Score measured by DXA
- Vertebral fractures
- Multiple (>2) low trauma peripheral fractures
- Disease/disorder known to influence bone metabolism
- History of major upper gastro-intestinal (GI) disease
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 |
|---|---|---|
| ibandronate, calcium and vitamin D1: 150 mg ibandronate monthly plus 500mg calcium and 800 UI vitamin D daily or | Drug | ibandronate |
| placebo,calcium and vitamin D2: placebo monthly plus 500mg calcium and 800 UI vitamin D daily | Drug | 2 |
Primary outcome
BV/TV and trab. Sp. measured by 3D pQCT device
Time frame: Baseline and after 3, 6, 9 and 12 months
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 28 Jan 2009.
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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.
Dieter Felsenberg, Prof. Dr. principal investigator
Centre for Muscle and Bone Research, Charité - Campus Benjamin Franklin, Berlin, 12200, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ibandronate, calcium and vitamin D in people with Osteoporosis, Postmenopausal, run by Charite University, Berlin, Germany at 1 site in Germany.
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 6 inclusion and 19 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 28 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
BV/TV and trab. Sp. measured by 3D pQCT device (time frame: Baseline and after 3, 6, 9 and 12 months). 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 28 Jan 2009.