OsteoporosisNCT00655681
Prevention of Post Operative Bone Loss in Children
A study testing pamidronate and saline in people with Osteoporosis and Cerebral Palsy, run by University of New Mexico at 1 site in United States.
Trial summary
Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk for low bone density Plan: children with chronic disease such as CP, spina bifida, etc. will be recruited pre operatively and studied with DXA scan. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Osteoporosis, Cerebral Palsy, Spina Bifida
- What is being tested?
- pamidronate and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2011
- Phase
- Interventional
- 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 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- chronic condition predisposing to low bone density, such as cerebral palsy, osteogenesis imperfecta
- lower extremity surgery proposed that will require post op nonweightbearing, casted or not, for a minimum of 4 weeks
Who cannot join
- creatinine >1.2
- prior bisphosphonate exposure
- orthopaedic implants in distal femoral precluding DXA scan
- inability to cooperate with DXA scan
Trial locations and contacts
1 site in 1 country.
United States1 site
University of New Mexico Carrie Tingley Hospital
Albuquerque, New Mexico, 87102
About this study
Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk for low bone density
Plan: children with chronic disease such as CP, spina bifida, etc. will be recruited pre operatively and studied with DXA scan. After surgery, children will be randomized to receive either pamidronate or saline. Repeat DXA scan will determine bone lost after end of immobilization or nonweightbearing.
Read the detailed description
Children at risk for post operative bone loss will be studied with preoperative DXA scan of spine and distal femora
Preoperative screening with standard labs electrolytes, Ca++, PO4, creatinine, Vit D
Following surgery of hip(s) or lower extremities, randomization into treatment with low dose IV pamidronate (one dose) v placebo group
Repeat DXA scan after end of immobilization or non-weightbearing
- Conditions
- Osteoporosis, Cerebral Palsy, Spina Bifida, Osteopenia, Osteogenesis Imperfecta
- Being tested
- pamidronate, saline
- Keywords
- pediatric osteoporosis, pediatric osteopenia, pamidronate, post operative osteopenia
- Medical subject headings
- Osteoporosis, Cerebral Palsy, Spinal Dysraphism, Bone Diseases, Metabolic, Osteogenesis Imperfecta, Juvenile osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pamidronateDrug
Also called Aredia
The pamidronate is mixed 1 to 10 (10 cc of saline for each 1 mg pamidronate), with a minimum volume of 50 cc saline. The medication is administered as an IV infusion to run at a rate beginning at 20 cc/hr, adjusting the rate so that the infusion will run over 4 hours. For children < 8 kg (80cc infusion), the rate would be 20 cc/hr and the duration would be determined by the volume.
salineOther
Also called normal saline
receives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids
| Study group | Role | What they receive |
|---|---|---|
| A recieveds pamidronate 1mg/kg once | Experimental | Receives pamidronate 1mg/kg once Receives: Drug: pamidronate |
| B: placebo group recieves saline | Placebo comparator | receives saline injection 10 cc/kg over 4 hours once post operatively Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan
Mean change lumbar spine post-op BMD Mean Right metaphyseal femur change post op BMD Mean Right transitional femur change post op BMD Mean Right diaphyseal femur change post op BMD
Mean Left metaphyseal femur change post op BMD Mean Left transitional femur change post op BMD Mean Left diaphyseal femur change post op BMD
Measured: Preoperative to post-operative DXA scan (4-12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2008 (estimated)
- Study startSep 2007
- Primary completionAug 2011
- Study completionAug 2011
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 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Elizabeth A Szalay, MD, Principal investigator, University of New Mexico Carrie Tingley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00655681
- Sponsor's protocol ID
- 07-213
- Status last verified
- Jul 2023
- First submitted
- 4 Apr 2008
- Last updated
- 22 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Post Operative Bone Loss in Children
- ClinicalTrials.gov ID
- NCT00655681
- Acronym / sponsor ID
- 07-213
- Conditions
- Osteoporosis, Cerebral Palsy, Spina Bifida, Osteopenia, Osteogenesis Imperfecta
- Keywords
- pediatric osteoporosis, pediatric osteopenia, pamidronate, post operative osteopenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Sep 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 10 Apr 2008 (estimated)
- Results
- Posted 22 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis: one-dose pamidronate will prevent post-operative bone loss in children at risk for low bone density
Plan: children with chronic disease such as CP, spina bifida, etc. will be recruited pre operatively and studied with DXA scan. After surgery, children will be randomized to receive either pamidronate or saline. Repeat DXA scan will determine bone lost after end of immobilization or nonweightbearing.
Detailed description
Children at risk for post operative bone loss will be studied with preoperative DXA scan of spine and distal femora
Preoperative screening with standard labs electrolytes, Ca++, PO4, creatinine, Vit D
Following surgery of hip(s) or lower extremities, randomization into treatment with low dose IV pamidronate (one dose) v placebo group
Repeat DXA scan after end of immobilization or non-weightbearing
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A recieveds pamidronate 1mg/kg once | Experimental | Drug: pamidronateReceives pamidronate 1mg/kg once |
| B: placebo group recieves saline | Placebo comparator | Other: salinereceives saline injection 10 cc/kg over 4 hours once post operatively |
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- chronic condition predisposing to low bone density, such as cerebral palsy, osteogenesis imperfecta
- lower extremity surgery proposed that will require post op nonweightbearing, casted or not, for a minimum of 4 weeks
Key exclusion criteria (4 listed)
- creatinine >1.2
- prior bisphosphonate exposure
- orthopaedic implants in distal femoral precluding DXA scan
- inability to cooperate with DXA scan
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 |
|---|---|---|
| pamidronateAlso: ArediaThe pamidronate is mixed 1 to 10 (10 cc of saline for each 1 mg pamidronate), with a minimum volume of 50 cc saline. The medication is administered as an IV infusion to run at a rate beginning at 20 cc/hr, adjusting the rate so that the infusion will run over 4 hours. For children < 8 kg (80cc infusion), the rate would be 20 cc/hr and the duration would be determined by the volume. | Drug | A recieveds pamidronate 1mg/kg once |
| salineAlso: normal salinereceives saline 10cc/kg over 4 hours post operatively in addition to routine post operative fluids | Other | B: placebo group recieves saline |
Primary outcome
Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan
Time frame: Preoperative to post-operative DXA scan (4-12 weeks)
Mean change lumbar spine post-op BMD Mean Right metaphyseal femur change post op BMD Mean Right transitional femur change post op BMD Mean Right diaphyseal femur change post op BMD Mean Left metaphyseal femur change post op BMD Mean Left transitional femur change post op BMD Mean Left diaphyseal femur change post op BMD
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- 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.
Elizabeth A Szalay, MD principal investigator
University of New Mexico Carrie Tingley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pamidronate and saline in people with Osteoporosis and Cerebral Palsy, run by University of New Mexico at 1 site 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 2 inclusion and 4 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 22 Aug 2023. 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 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. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2023). 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?
Amount of Bone Density Lost (%) From pre-to Post-operative DXA Scan (time frame: Preoperative to post-operative DXA scan (4-12 weeks)). 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 22 Aug 2023.