Prevention of Steroid-Induced Osteoporosis in Children
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ClinicalTrials.gov Identifier: NCT00022841 |
Recruitment Status
:
Terminated
(Inadequate eligible subjects to expect sufficient numbers to analyse outcomes.)
First Posted
: August 16, 2001
Last Update Posted
: December 19, 2007
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteoporosis | Drug: Pamidronate | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Prevention of Steroid-Induced Osteoporosis in Children |
Actual Study Completion Date : | September 2005 |

- Lumbar spine BMD determined by DEXA [ Time Frame: Measured at Month 24 ]
- 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 ]

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Ages Eligible for Study: | 5 Years and older (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00022841
United States, Missouri | |
Washington University Medical School-St. Louis Children's Hospital | |
St. Louis, Missouri, United States, 63110 |
Principal Investigator: | Rebecca P. Green, MD, PhD | Washington University Medical School-St. Louis Children's Hospital |
ClinicalTrials.gov Identifier: | NCT00022841 History of Changes |
Other Study ID Numbers: |
K23AR002161 ( U.S. NIH Grant/Contract ) NIAMS-065 |
First Posted: | August 16, 2001 Key Record Dates |
Last Update Posted: | December 19, 2007 |
Last Verified: | December 2007 |
Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Bone mineral density (BMD) Children Glucocorticoids Osteoporosis |
Pediatric Pamidronate Steroids |
Additional relevant MeSH terms:
Osteoporosis Bone Diseases, Metabolic Bone Diseases Musculoskeletal Diseases Metabolic Diseases |