OsteoporosisPhase 4NCT01882400
Assessment of Response to Treatment of Osteoporosis With Oral Bisphosphonates in Patients With Muscular Dystrophy
A Phase 4 study testing Bisphosphonate treatment in people with Osteoporosis and Muscular Dystrophy, run by Gilles Boire at 1 site in Canada.
Trial summary
By supplying an adequate amount of calcium and vitamin D with the addition of weekly bisphosphonate, the investigators will be able to increase bone mass and decrease the incidence of fragility fractures in these children with muscular dystrophy. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Osteoporosis, Muscular Dystrophy, Cystic Fibrosis
- What is being tested?
- Bisphosphonate treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteCanada
- Study dates
- May 2001to 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Osteoporosis or osteopenia
- Severe muscular dystrophy or cystic fibrosis
- May use corticosteroids
Who cannot join
- Inability to consent or to take drugs by mouth
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, J1H 5N4
About this study
Official title: Évaluation Multidimensionnelle de la réponse au Traitement de l'ostéoporose spontanée et Induite Par Les corticostéroïdes à l'Aide d'un Bisphosphonate à Administration Orale Chez Des Malades Porteurs d'Une Dystrophie Musculaire sévère.
By supplying an adequate amount of calcium and vitamin D with the addition of weekly bisphosphonate, the investigators will be able to increase bone mass and decrease the incidence of fragility fractures in these children with muscular dystrophy.
The investigators think this treatment will also decrease the intensity of pain frequently present in these patients and slow the progression of scoliosis.
Read the detailed description
Children with muscular dystrophy, as well as children with other chronic diseases (e.g. cystic fibrosis, chronic inflammatory arthritis) are at risk to develop fragility fractures both due to the disease itself and to drugs (mostly corticosteroids) used to treat the diseases.
In addition, children with muscular dystrophy frequently complain of diffuse pain making daily care more difficult and almost always develop structural scoliosis.
The objective of the present protocol is to offer these children a preventive treatment aimed at maintaining or increasing their bone mass. We also propose that maintaining bone mass will decrease fracture rates, as well as pain and the rate of progression of scoliosis.
Rigorous care to ensure adequate intake of calcium and vitamin D, as well as addition of a weekly bisphosphonate, are the central aspect of the project. In addition, we will monitor to avoid possible side-effects such as hypercalciuria and kidney stones.
- Conditions
- Osteoporosis, Muscular Dystrophy, Cystic Fibrosis
- Being tested
- Bisphosphonate treatment
- Keywords
- Osteoporosis, Severe muscular dystrophy, Cystic fibrosis
- Medical subject headings
- Osteoporosis, Muscular Dystrophies, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bisphosphonate treatmentDrug
Also called Risedronate, Alendronate
Treatment with Calcium, vitamin D and a weekly bisphosphonate. Comparison of bone mass, fracture rate, pain intensity and scoliosis progression before and after treatment
| Study group | Role | What they receive |
|---|---|---|
| Bisphosphonate treatment | Experimental | Add a weekly bisphosphonate to adequate doses of calcium and vitamin D supplements Receives: Drug: Bisphosphonate treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase in bone density according to osteodensitometry
comparing successive bone densitometry
Measured: Over 2 years of treatment
Secondary outcomes (2)
Decrease in bone pain
comparing reports of bone pain
Measured: Over the first 2 years of treatment
Retardation of scoliosis development
computing how many patients had to have scoliosis surgery
Measured: Over the first 2 years of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startMay 2001
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilles Boire
- Sponsor type
- University, hospital or other
- Collaborators
- Procter and Gamble
- Responsible party
- Sponsor-investigator, Gilles Boire, Université de Sherbrooke
- Investigators
- Gilles Boire, MD, MSc, Principal investigator, CHUS and Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01882400
- Sponsor's protocol ID
- 01-12
- Other IDs
- Unrestricted grant
- Status last verified
- Jan 2018
- First submitted
- 17 Jun 2013
- Last updated
- 9 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jeffery TC, Chang AB, Conwell LS. Bisphosphonates for osteoporosis in people with cystic fibrosis. Cochrane Database Syst Rev. 2023 Jan 10;1(1):CD002010. doi: 10.1002/14651858.CD002010.pub5.
PubMed 36625789
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Évaluation Multidimensionnelle de la réponse au Traitement de l'ostéoporose spontanée et Induite Par Les corticostéroïdes à l'Aide d'un Bisphosphonate à Administration Orale Chez Des Malades Porteurs d'Une Dystrophie Musculaire sévère.
- ClinicalTrials.gov ID
- NCT01882400
- Acronym / sponsor ID
- 01-12
- Conditions
- Osteoporosis, Muscular Dystrophy, Cystic Fibrosis
- Keywords
- Osteoporosis, Severe muscular dystrophy, Cystic fibrosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Gilles BoireUniversity, hospital or other
- Collaborators
- Procter and Gamble
- Study start
- May 2001
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 20 Jun 2013 (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.
By supplying an adequate amount of calcium and vitamin D with the addition of weekly bisphosphonate, the investigators will be able to increase bone mass and decrease the incidence of fragility fractures in these children with muscular dystrophy.
The investigators think this treatment will also decrease the intensity of pain frequently present in these patients and slow the progression of scoliosis.
Detailed description
Children with muscular dystrophy, as well as children with other chronic diseases (e.g. cystic fibrosis, chronic inflammatory arthritis) are at risk to develop fragility fractures both due to the disease itself and to drugs (mostly corticosteroids) used to treat the diseases.
In addition, children with muscular dystrophy frequently complain of diffuse pain making daily care more difficult and almost always develop structural scoliosis.
The objective of the present protocol is to offer these children a preventive treatment aimed at maintaining or increasing their bone mass. We also propose that maintaining bone mass will decrease fracture rates, as well as pain and the rate of progression of scoliosis.
Rigorous care to ensure adequate intake of calcium and vitamin D, as well as addition of a weekly bisphosphonate, are the central aspect of the project. In addition, we will monitor to avoid possible side-effects such as hypercalciuria and kidney stones.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bisphosphonate treatment | Experimental | Drug: Bisphosphonate treatmentAdd a weekly bisphosphonate to adequate doses of calcium and vitamin D supplements |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Osteoporosis or osteopenia
- Severe muscular dystrophy or cystic fibrosis
- May use corticosteroids
Key exclusion criteria (1 listed)
- Inability to consent or to take drugs by mouth
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 |
|---|---|---|
| Bisphosphonate treatmentAlso: Risedronate, AlendronateTreatment with Calcium, vitamin D and a weekly bisphosphonate. Comparison of bone mass, fracture rate, pain intensity and scoliosis progression before and after treatment | Drug | Bisphosphonate treatment |
Primary outcome
Increase in bone density according to osteodensitometry
Time frame: Over 2 years of treatment
comparing successive bone densitometry
2 secondary outcomes
Decrease in bone pain
Time frame: Over the first 2 years of treatment
Retardation of scoliosis development
Time frame: Over the first 2 years of treatment
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 9 Jan 2018.
- Derived from this study: PubMed 36625789Jeffery TC, Chang AB, Conwell LS. Bisphosphonates for osteoporosis in people with cystic fibrosis. Cochrane Database Syst Rev. 2023 Jan 10;1(1):CD002010. doi: 10.1002/14651858.CD002010.pub5.
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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.
Gilles Boire, MD, MSc principal investigator
CHUS and Université de Sherbrooke
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 Bisphosphonate treatment in people with Osteoporosis and Muscular Dystrophy, run by Gilles Boire at 1 site in Canada.
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 1 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 9 Jan 2018. 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 Canada. 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 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?
Increase in bone density according to osteodensitometry (time frame: Over 2 years of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01882400, which also lists 1 linked publication.
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 9 Jan 2018.