Back to resultsPrevention of Steroid-Induced Osteoporosis in Children
Primary Purpose
Osteoporosis
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pamidronate
Sponsored by
About this trial
This is an interventional treatment trial for Osteoporosis focused on measuring Bone mineral density (BMD), Children, Glucocorticoids, Osteoporosis, Pediatric, Pamidronate, Steroids
Eligibility Criteria
Inclusion Criteria: 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 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.
Sites / Locations
- Washington University Medical School-St. Louis Children's Hospital
Outcomes
Primary Outcome Measures
Lumbar spine BMD determined by DEXA
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00022841
First Posted
August 14, 2001
Last Updated
December 14, 2007
Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1. Study Identification
Unique Protocol Identification Number
NCT00022841
Brief Title
Prevention of Steroid-Induced Osteoporosis in Children
Official Title
Prevention of Steroid-Induced Osteoporosis in Children
Study Type
Interventional
2. Study Status
Record Verification Date
December 2007
Overall Recruitment Status
Terminated
Why Stopped
Inadequate eligible subjects to expect sufficient numbers to analyse outcomes.
Study Start Date
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Primary Completion Date
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Study Completion Date
September 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4. Oversight
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoporosis
Keywords
Bone mineral density (BMD), Children, Glucocorticoids, Osteoporosis, Pediatric, Pamidronate, Steroids
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Pamidronate
Primary Outcome Measure Information:
Title
Lumbar spine BMD determined by DEXA
Time Frame
Measured at Month 24
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca P. Green, MD, PhD
Organizational Affiliation
Washington University Medical School-St. Louis Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University Medical School-St. Louis Children's Hospital
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Prevention of Steroid-Induced Osteoporosis in Children
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