OsteoporosisPhase 1/2NCT00022841
Prevention of Steroid-Induced Osteoporosis in Children
A Phase 1/2 study testing Pamidronate in people with Osteoporosis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the drug pamidronate can safely and effectively improve bone mineral density in growing children who have bone disease caused by taking steroid medications. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Pamidronate
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Sep 2005
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chronic inflammatory disease or transplant recipient, currently on steroid therapy at supraphysiologic dose (greater than hydrocortisone equivalent of 15 mg/m2/day) for more than 6 months
- Bone age less then 14 years in females, 16 years in males, to correspond to < 90% of peak BMD
- And
- Presence of glucocorticoid induced bone disease defined by:
- Presence of at least one atraumatic fracture (defined as fracture that occurs during activities of daily living, without a fall), or a vertebral fracture, OR
- AP lumbar spine BMD (determined by DEXA) of more than 2 or more SD below the mean lumbar BMD for a healthy child of similar stature (height age). OR
Show all 9Show fewer
- A low trauma fracture (suspicious fracture - defined as a fracture the occurs with a fall from standing height or below, and not during a high velocity activity) and AP spine BMD 1.5 or more SD below the mean for height age, OR
- Recent loss of BMD of greater then 3% over a 6 month or greater interval at any one of the following sites, lumbar spine, total hip or whole body (excluding head). OR
- Recent increase in BMD of less then 3% over a 12 month period at all of the three sites listed above.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Medical School-St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
The purpose of this study is to determine whether the drug pamidronate can safely and effectively improve bone mineral density in growing children who have bone disease caused by taking steroid medications. People who take steroid medications called glucocorticoids, like prednisone or dexamethasone, for long periods almost always have decreased bone density and are at increased risk of breaking a bone. Research has shown that pamidronate improves bone density in adults who take glucocorticoids. However, use of pamidronate is not approved in children because it has not been extensively tested in children. It is possible that children will have a different response or unique problems with the medication because their bones are still growing. We will assign all study participants to one of two groups. One group will receive pamidronate intravenously (through a vein) every 3 months in addition of daily oral calcium and vitamin D and the other group will receive calcium and vitamin D. The study is scheduled to run for 36 months, with visits to the study center once every 3 months.
Read the detailed description
This is a randomized study to determine whether pamidronate can safely and effectively improve bone mineral density (BMD) in children with glucocorticoid-induced osteoporosis. After we stratify participants on the basis of whether they are taking glucocorticoids for treatment of inflammatory disease or for immunosuppression following organ transplant, we will randomize them to receive daily calcium and vitamin D in addition to 30 mg/kg (1 mg/kg for weight less then 30 kg) of pamidronate in normal saline every 3 months or daily calcium and vitamin D only for 24 months, followed by a 12-month followup period off of therapy. We will measure endpoints at 24 months. The primary endpoint is lumbar spine BMD determined by DEXA. Secondary endpoints will include volumetric BMD of the spine, proximal femur BMD and volumetric BMD, total body bone mineral content (BMC), fracture incidence, bone turnover markers, and growth and skeletal changes. The study radiologist will be blinded to treatment group.
- Conditions
- Osteoporosis
- Being tested
- Pamidronate
- Keywords
- Bone mineral density (BMD), Children, Glucocorticoids, Osteoporosis, Pediatric, Pamidronate, Steroids
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PamidronateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Lumbar spine BMD determined by DEXA
Measured: Measured at Month 24
Secondary outcomes (1)
BMD of the spine, proximal femur BMD and volumetric BMD, total body bone mineral content (BMC), fracture incidence, bone turnover markers, and growth and skeletal changes
Measured: Measured at Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2001 (estimated)
- Study completionSep 2005
Why it stopped: Inadequate eligible subjects to expect sufficient numbers to analyse outcomes.
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Investigators
- Rebecca P. Green, MD, PhD, Principal investigator, Washington University Medical School-St. Louis Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022841
- Sponsor's protocol ID
- K23AR002161
- Other IDs
- NIAMS-065
- Status last verified
- Dec 2007
- First submitted
- 14 Aug 2001
- Last updated
- 19 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Steroid-Induced Osteoporosis in Children
- ClinicalTrials.gov ID
- NCT00022841
- Acronym / sponsor ID
- K23AR002161
- Conditions
- Osteoporosis
- Keywords
- Bone mineral density (BMD), Children, Glucocorticoids, Osteoporosis, Pediatric, Pamidronate, Steroids
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate eligible subjects to expect sufficient numbers to analyse outcomes.
- Enrolment
- 40 participants
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study completion
- Sep 2005 (actual)
- First posted
- 16 Aug 2001 (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 determine whether the drug pamidronate can safely and effectively improve bone mineral density in growing children who have bone disease caused by taking steroid medications. People who take steroid medications called glucocorticoids, like prednisone or dexamethasone, for long periods almost always have decreased bone density and are at increased risk of breaking a bone. Research has shown that pamidronate improves bone density in adults who take glucocorticoids. However, use of pamidronate is not approved in children because it has not been extensively tested in children. It is possible that children will have a different response or unique problems with the medication because their bones are still growing. We will assign all study participants to one of two groups. One group will receive pamidronate intravenously (through a vein) every 3 months in addition of daily oral calcium and vitamin D and the other group will receive calcium and vitamin D. The study is scheduled to run for 36 months, with visits to the study center once every 3 months.
Detailed description
This is a randomized study to determine whether pamidronate can safely and effectively improve bone mineral density (BMD) in children with glucocorticoid-induced osteoporosis. After we stratify participants on the basis of whether they are taking glucocorticoids for treatment of inflammatory disease or for immunosuppression following organ transplant, we will randomize them to receive daily calcium and vitamin D in addition to 30 mg/kg (1 mg/kg for weight less then 30 kg) of pamidronate in normal saline every 3 months or daily calcium and vitamin D only for 24 months, followed by a 12-month followup period off of therapy. We will measure endpoints at 24 months. The primary endpoint is lumbar spine BMD determined by DEXA. Secondary endpoints will include volumetric BMD of the spine, proximal femur BMD and volumetric BMD, total body bone mineral content (BMC), fracture incidence, bone turnover markers, and growth and skeletal changes. The study radiologist will be blinded to treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Chronic inflammatory disease or transplant recipient, currently on steroid therapy at supraphysiologic dose (greater than hydrocortisone equivalent of 15 mg/m2/day) for more than 6 months
- Bone age less then 14 years in females, 16 years in males, to correspond to < 90% of peak BMD
- And
- Presence of glucocorticoid induced bone disease defined by:
- Presence of at least one atraumatic fracture (defined as fracture that occurs during activities of daily living, without a fall), or a vertebral fracture, OR
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Pamidronate | Drug | – |
Primary outcome
Lumbar spine BMD determined by DEXA
Time frame: Measured at Month 24
1 secondary outcome
BMD of the spine, proximal femur BMD and volumetric BMD, total body bone mineral content (BMC), fracture incidence, bone turnover markers, and growth and skeletal changes
Time frame: Measured at Month 24
Results and safety
The study was stopped early (reason given: Inadequate eligible subjects to expect sufficient numbers to analyse outcomes.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2007.
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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.
Rebecca P. Green, MD, PhD principal investigator
Washington University Medical School-St. Louis Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pamidronate in people with Osteoporosis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) 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 9 inclusion and 0 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 19 Dec 2007. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Inadequate eligible subjects to expect sufficient numbers to analyse outcomes.). 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?
Lumbar spine BMD determined by DEXA (time frame: Measured at Month 24). 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 19 Dec 2007.