OsteoporosisPhase 3NCT00822029
Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy
A Phase 3 study testing FOSAMAX in people with Osteoporosis and Cerebral Palsy, run by Department of Clinical Research and Innovation at 1 site in France.
Trial summary
It is a double blind randomized study aiming at estimating the efficiency of oral bisphosphonates on the decrease of osteoporosis by comparing the evolution of densitometric values between two groups of children (treatment versus placebo). Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Osteoporosis, Cerebral Palsy
- What is being tested?
- FOSAMAX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Feb 2011
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- non-walking children with cerebral palsy
- weight > to or = 20 kg
- aged between 10 to 18 years old
- with a Z-score (spinal and / or femoral) <-2 DS
- with a good dental status
- capable of holding the seated or half seated position for 30 minutes
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- capable of filling the study questionary
- with negative blood pregnancy tests on inclusion for pubescent girls
- Using valid contraception means (condoms, oral contraception) for pubescent girls for the whole study duration and 6 months after the end of the study
- affiliated to the social security regimen
Who cannot join
- history of spine arthrodesis with osteosynthesis
- gastro-oesophageal reflux
- oesophagal disease or any factor leading to a delaying or slowing the oesophagal transit (such as stenosis or achalasy)
- severe difficulties in swallowing
- renal failure
- history of uveitis
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- hypersensibility to alendronate or to one of its excipients (microcristalline cellulose, lactose anhydre, croscarmellose sodium, magnesium stearate)
- deficiency in calcium or in vitamine D
- calcium malabsorption
- hereditary galactose intolerance, congenital galactosemia, glucose and galactose malabsorption syndrome
- evolutive affection of the upper gastro-intestinal tract such as dysphagia (other than neurological), gastritis, duodenitis, gastro-duodenal ulcers (or with history of ulcers in the previous year), evolutive gastro-intestinal bleeding or history of surgery of the upper gastro-intestinal tract (gastrostomy in particular)
- history of necrosis of the maxillar bone or of uncovering of the bone or of cicatrisation delay after a dental surgery
- emancipated minor
- prior treatment with bisphosphonates
Trial locations and contacts
1 site in 1 country.
About this study
It is a double blind randomized study aiming at estimating the efficiency of oral bisphosphonates on the decrease of osteoporosis by comparing the evolution of densitometric values between two groups of children (treatment versus placebo).
Read the detailed description
In non walking children with cerebral palsy, osteoporosis is responsible for bone pains and iterative fractures. Classical treatments include physiotherapy, assisted verticalisation by orthesis and correct feeding with vitamin D and calcium supplementation. Yet this isn't always sufficient and isn't always possible.
Bisphosphonates, which have been used for years in the treatment of post-menopausic osteoporosis or of osteogenesis imperfecta in children, can turn out to be very useful for non-walking children with cerebral palsy.
Studies have been published since 1994 in this indication with encouraging results. Cyclic intravenous administration of bisphosphonates every 3 months showed an objective increase in bone density and a decrease in pains and fractures after one year of treatment. Cyclic intravenous administration nevertheless requires the use of an implanted chamber and iterative hospitalizations. Oral administration should allow to treat these children, who already have many treatments, in a simpler way.
The study will concern 40 non-walking children with cerebral palsy aged over 10 years.
- Conditions
- Osteoporosis, Cerebral Palsy
- Being tested
- FOSAMAX, PLACEBO
- Medical subject headings
- Osteoporosis, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FOSAMAXDrug
patient receiving one tablet (oral use) 70 mg Fosamax by week
PLACEBOOther
patient receiving one tablet (oral use) placebo by week
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | FOSAMAX (oral bisphosphonate) Receives: Drug: FOSAMAX |
| 2 | Placebo comparator | PLACEBO Receives: Other: PLACEBO |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the efficiency of oral bisphosphonates on the decrease of osteoporosis assessed by osteodensitometry.
Measured: one year
Secondary outcomes (1)
To estimate the improvement of the biological and clinical consequences (bone pains and fractures) of osteoporosis. To estimate the improvement of the quality of life To estimate the tolerance of oral bisphosphonates.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Why it stopped: only 2 patients inclued and Study Principal Investigator has left the hospital
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Clinical Research and Innovation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Department of Clinical Research and Innovation, Centre Hospitalier Universitaire de Nice
- Investigators
- Jacques GRIFFET, PhD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00822029
- Sponsor's protocol ID
- 2006-005678-36
- Status last verified
- Nov 2011
- First submitted
- 13 Jan 2009
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Oral Bisphosphonates in the Treatment of Osteoporosis of Non-walking Children With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT00822029
- Acronym / sponsor ID
- 2006-005678-36
- Conditions
- Osteoporosis, Cerebral Palsy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: only 2 patients inclued and Study Principal Investigator has left the hospital
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Department of Clinical Research and InnovationUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 14 Jan 2009 (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.
It is a double blind randomized study aiming at estimating the efficiency of oral bisphosphonates on the decrease of osteoporosis by comparing the evolution of densitometric values between two groups of children (treatment versus placebo).
Detailed description
In non walking children with cerebral palsy, osteoporosis is responsible for bone pains and iterative fractures. Classical treatments include physiotherapy, assisted verticalisation by orthesis and correct feeding with vitamin D and calcium supplementation. Yet this isn't always sufficient and isn't always possible.
Bisphosphonates, which have been used for years in the treatment of post-menopausic osteoporosis or of osteogenesis imperfecta in children, can turn out to be very useful for non-walking children with cerebral palsy.
Studies have been published since 1994 in this indication with encouraging results. Cyclic intravenous administration of bisphosphonates every 3 months showed an objective increase in bone density and a decrease in pains and fractures after one year of treatment. Cyclic intravenous administration nevertheless requires the use of an implanted chamber and iterative hospitalizations. Oral administration should allow to treat these children, who already have many treatments, in a simpler way.
The study will concern 40 non-walking children with cerebral palsy aged over 10 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: FOSAMAXFOSAMAX (oral bisphosphonate) |
| 2 | Placebo comparator | Other: PLACEBOPLACEBO |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- non-walking children with cerebral palsy
- weight > to or = 20 kg
- aged between 10 to 18 years old
- with a Z-score (spinal and / or femoral) <-2 DS
- with a good dental status
Key exclusion criteria (14 listed)
- history of spine arthrodesis with osteosynthesis
- gastro-oesophageal reflux
- oesophagal disease or any factor leading to a delaying or slowing the oesophagal transit (such as stenosis or achalasy)
- severe difficulties in swallowing
- renal failure
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 |
|---|---|---|
| FOSAMAXpatient receiving one tablet (oral use) 70 mg Fosamax by week | Drug | 1 |
| PLACEBOpatient receiving one tablet (oral use) placebo by week | Other | 2 |
Primary outcome
To estimate the efficiency of oral bisphosphonates on the decrease of osteoporosis assessed by osteodensitometry.
Time frame: one year
1 secondary outcome
To estimate the improvement of the biological and clinical consequences (bone pains and fractures) of osteoporosis. To estimate the improvement of the quality of life To estimate the tolerance of oral bisphosphonates.
Time frame: one year
Results and safety
The study was stopped early (reason given: only 2 patients inclued and Study Principal Investigator has left the hospital). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
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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.
Jacques GRIFFET, PhD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FOSAMAX in people with Osteoporosis and Cerebral Palsy, run by Department of Clinical Research and Innovation at 1 site in France.
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 10 inclusion and 14 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: stopped early, as of the sponsor's last update on 26 Mar 2012. 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 France. 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 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 was stopped early (reason given: only 2 patients inclued and Study Principal Investigator has left the hospital). Results are not available in the source record.
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?
To estimate the efficiency of oral bisphosphonates on the decrease of osteoporosis assessed by osteodensitometry. (time frame: one year). 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 26 Mar 2012.