Prevention of Steroid-Induced Osteoporosis in Children - Full Text View

Sponsored by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by:	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier:	NCT00022841

Purpose

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.

Condition	Intervention	Phase
Osteoporosis	Drug: Pamidronate	Phase I Phase II

MedlinePlus related topics: Minerals Osteoporosis

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prevention of Steroid-Induced Osteoporosis in Children

Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:

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

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 [ Time Frame: Measured at Month 24 ]

Estimated Enrollment:	40
Study Completion Date:	September 2005

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.

Eligibility

Ages Eligible for Study:	5 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00022841

Locations

United States, Missouri
Washington University Medical School-St. Louis Children's Hospital
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

Principal Investigator:

Rebecca P. Green, MD, PhD

Washington University Medical School-St. Louis Children's Hospital

More Information

No publications provided

Study ID Numbers:	K23 AR02161, NIAMS-065
Study First Received:	August 14, 2001
Last Updated:	December 14, 2007
ClinicalTrials.gov Identifier:	NCT00022841 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Bone mineral density (BMD)
Children
Glucocorticoids
Osteoporosis

Pediatric
Pamidronate
Steroids

Study placed in the following topic categories:

Musculoskeletal Diseases
Pamidronate
Osteoporosis
Bone Density Conservation Agents

Bone Diseases, Metabolic
Glucocorticoids
Bone Diseases

Additional relevant MeSH terms:

Musculoskeletal Diseases
Physiological Effects of Drugs
Pamidronate
Osteoporosis

Bone Density Conservation Agents
Bone Diseases, Metabolic
Bone Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 06, 2009