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

NCT ID: NCT00145704

Last Updated: 2013-04-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-06-30
• Study Completion Date: 2008-10-31

Brief Summary

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.

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.

Conditions

Osteopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Vitamin D supplement

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D given to patients with growth hormone deficiency

Calcium

Intervention Type: DIETARY_SUPPLEMENT

calcium supplement given to patients with growth hormone deficiency

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

Group Type: EXPERIMENTAL

bisphosphonate therapy (risedronate)

Intervention Type: DRUG

Bisphosphonate therapy given to patients with growth hormone deficiency

Vitamin D supplement

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D given to patients with growth hormone deficiency

Calcium

Intervention Type: DIETARY_SUPPLEMENT

calcium supplement given to patients with growth hormone deficiency

Interventions

bisphosphonate therapy (risedronate)

Bisphosphonate therapy given to patients with growth hormone deficiency

Intervention Type: DRUG

Vitamin D supplement

Vitamin D given to patients with growth hormone deficiency

Intervention Type: DIETARY_SUPPLEMENT

Calcium

calcium supplement given to patients with growth hormone deficiency

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Over the counter Vitamin D 400 IU.

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

State University of New York - Upstate Medical University

OTHER

Sponsor Role: lead

Responsible Party

Timothy Damron, M.D.

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Timothy A Damron, MD

Role: PRINCIPAL_INVESTIGATOR

State University of New York - Upstate Medical University

Locations

Upstate Medical University

Syracuse, New York, United States

Countries

United States

Other Identifiers

SUNY UMU IRB # 4689

Identifier Type: -

Identifier Source: org_study_id