Musculoskeletal Diseases

All Conditions

Nutritional and Metabolic Diseases

Rare Diseases

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Growth Hormone Deficiency

Isolated Growth Hormone Deficiency

All Drugs and Chemicals

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Vitamin D

Cholecalciferol

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Diphosphonates

Risedronic Acid

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Calcium Channel Blockers

Vitamin D3

Calciferol

Calcium Supplement

Ergocalciferol

Vitamin D2

No bisphosphonate therapy given, participants will take Vitamin D 400 IU daily for 18 months, as well as calcium carbonate 500 mg twice a day for 18 months.

Bisphosphonate Therapy-Risedronate 35 mg once a week for 18 months, Vitamin D 400 IU daily for 18 months and calcium carbonate 500 mg twice daily for 18 months

Bisphosphonate therapy given to patients with growth hormone deficiency

bisphosphonate therapy (risedronate)

Vitamin D given to patients with growth hormone deficiency

Vitamin D supplement

calcium supplement given to patients with growth hormone deficiency

Timothy A Damron, MD

The purpose of this project is to evaluate the hypothesis that bisphosphonate treatment given to growth hormone deficient patients (regardless of current growth hormone replacement therapy status and without changing that status) significantly increases total body bone mineral density during an eighteen month period of treatment combined with calcium and Vitamin D when compared to calcium and Vitamin D treatment alone.

Adult patients with Dexa scan (bone scan) z-scores \< -1.0 (meaning low bone density) in at least one site will be selected for randomization. All patients who qualify for randomization will undergo baseline bloodwork for serum bone specific alkaline phosphatase (BSAP) and n-terminal telopeptides of collagen (NTX) levels. Recent bloodwork obtained as part of their ongoing long-term Pediatric Oncology and/or Endocrine clinic follow-up evaluation will be reviewed to exclude any baseline correctable confounding causes of osteopenia (low bone density). All women of childbearing potential will have a pregnancy test.

For those patients already on growth hormone replacement therapy, growth hormone will be administered as per standard of care, with standard dose ranges adjusted based upon IGF-1(Insulin like growth factor) monitoring. Those patients not currently receiving growth hormone replacement therapy will not be placed on therapy as a part of this study. Patients on and off growth hormone replacement therapy will be randomized in a block design to the two treatment arms to assure equal numbers in each treatment arm. The bisphosphonate to be utilized will be provided to the Arm II patients at no charge. All Arm II patients will receive the same bisphosphonate regimen, Risedronate 35 mg per oral once weekly for 18 months. All patients on arms I and II will also receive Vitamin D (400 IU p.o. daily) and calcium carbonate (500 mg p.o. twice daily) free of charge for eighteen months.

Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density

Treatment of Childhood Cancer Therapy-induced Osteopenia in Growth Hormone Deficient Adult Survivors: Does Bisphosphonate Treatment Improve Bone Mineral Density?

For those patients already on growth hormone replacement therapy, growth hormone will be administered as per standard of care, with standard dose ranges adjusted based upon IGF-1 monitoring. Those patients not currently receiving growth hormone replacement therapy will not be placed on therapy as a part of this study. Patients on and off growth hormone replacement therapy will be randomized in a block design to the two treatment arms to assure equal numbers in each treatment arm. The bisphosphonate to be utilized will be provided to the Arm II patients at no charge. All Arm II patients will receive the same bisphosphonate regimen, Risedronate 35 mg per oral once weekly for 18 months. All patients on arms I and II will also receive Vitamin D (400 IU p.o. daily) and calcium carbonate (500 mg p.o. twice daily) free of charge for eighteen months.

Genentech, Inc.

State University of New York - Upstate Medical University

Professor

bisphosphonate use and growth hormone use

Bisphosphonate and Growth Hormone Use

Growth hormone use only, no bisphosphonate used

Growth Hormone Only

Total

Age Continuous

Sex: Female, Male

Early termination due to low enrollment, and lost to follow up of three subjects. Data was limited and therefore not reviewed/analyzed

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density	NCT00145704	Osteopenia	bisphosphonate ... Vitamin D suppl... Calcium	18 Years -	State University of New York - Upstate Medical University
Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density	NCT00145704	Osteopenia	bisphosphonate ... Vitamin D suppl... Calcium	18 Years -	State University of New York - Upstate Medical University
Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density	NCT00145704	Osteopenia	bisphosphonate ... Vitamin D suppl... Calcium	18 Years -	State University of New York - Upstate Medical University
Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density	NCT00145704	Osteopenia	bisphosphonate ... Vitamin D suppl... Calcium	18 Years -	State University of New York - Upstate Medical University

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