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

This study has been terminated.
(due to low enrollment, participants are no longer being examined or treated)
Sponsor:
Collaborator:
Genentech
Information provided by (Responsible Party):
Timothy Damron, M.D., State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier:
NCT00145704
First received: September 1, 2005
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention
Osteopenia
Drug: bisphosphonate therapy (risedronate)
Dietary Supplement: Vitamin D supplement
Dietary Supplement: Calcium

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of Childhood Cancer Therapy-induced Osteopenia in Growth Hormone Deficient Adult Survivors: Does Bisphosphonate Treatment Improve Bone Mineral Density?

Resource links provided by NLM:


Further study details as provided by State University of New York - Upstate Medical University:

Primary Outcome Measures:
  • Change in Total Body Bone Mineral Density During an 18 Month Period [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 6
Study Start Date: June 2002
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Growth Hormone only
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.
Dietary Supplement: Vitamin D supplement
Vitamin D given to patients with growth hormone deficiency
Other Name: Over the counter Vitamin D 400 IU.
Dietary Supplement: Calcium
calcium supplement given to patients with growth hormone deficiency
Experimental: Growth Hormone & Bisphosphonate Therapy
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
Drug: bisphosphonate therapy (risedronate)
Bisphosphonate therapy given to patients with growth hormone deficiency
Dietary Supplement: Vitamin D supplement
Vitamin D given to patients with growth hormone deficiency
Other Name: Over the counter Vitamin D 400 IU.
Dietary Supplement: Calcium
calcium supplement given to patients with growth hormone deficiency

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Growth hormone deficiency as a complication of treatment for pediatric malignancy
  • Dexa (bone densitometry)with z-scores of < -1.0 in at least one site

Exclusion Criteria:

  • Dexa (bone densitometry)with z-scores < -1.0 in at least one site
  • Subjects <18 years old
  • Pregnant or lactating patients
  • Any contraindication for or unwillingness to consider bisphosphonate treatment
  • Inability or unwillingness to undergo bone density evaluation
  • Other correctable causes of decreased bone mineral density
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00145704

Locations
United States, New York
Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
State University of New York - Upstate Medical University
Genentech
Investigators
Principal Investigator: Timothy A Damron, MD State University of New York - Upstate Medical University
  More Information

No publications provided

Responsible Party: Timothy Damron, M.D., Professor, State University of New York - Upstate Medical University
ClinicalTrials.gov Identifier: NCT00145704     History of Changes
Other Study ID Numbers: SUNY UMU IRB # 4689
Study First Received: September 1, 2005
Results First Received: October 26, 2010
Last Updated: March 1, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by State University of New York - Upstate Medical University:
osteopenia
growth hormone deficiency
pediatric malignancy

Additional relevant MeSH terms:
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Calcium, Dietary
Diphosphonates
Vitamin D
Ergocalciferols
Vitamins
Hormones
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Micronutrients
Growth Substances
Hormones, Hormone Substitutes, and Hormone Antagonists
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014