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

NCT00145704 | Terminated Results

• 1 other identifier: SUNY UMU IRB # 4689
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteopenia

Keywords

osteopenia; growth hormone deficiency; pediatric malignancy

Outcome Measures

Primary Outcomes (1)

• Change in Total Body Bone Mineral Density During an 18 Month Period

  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.

  18 months

Study Arms (2)

Growth Hormone only

ACTIVE COMPARATOR

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; Dietary Supplement: Calcium

Growth Hormone & Bisphosphonate Therapy

EXPERIMENTAL

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); Dietary Supplement: Vitamin D supplement; Dietary Supplement: Calcium

Interventions

bisphosphonate therapy (risedronate) DRUG

Bisphosphonate therapy given to patients with growth hormone deficiency

Growth Hormone & Bisphosphonate Therapy

Vitamin D supplement DIETARY_SUPPLEMENT

Vitamin D given to patients with growth hormone deficiency

Also known as: Over the counter Vitamin D 400 IU.

Growth Hormone & Bisphosphonate Therapy; Growth Hormone only

Calcium DIETARY_SUPPLEMENT

calcium supplement given to patients with growth hormone deficiency

Growth Hormone & Bisphosphonate Therapy; Growth Hormone only

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• State University of New York - Upstate Medical University: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Upstate Medical University

Syracuse, New York, 13210, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Dwarfism, Pituitary

Interventions

Risedronic Acid; Calcium

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Dwarfism; Bone Diseases, Developmental; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Limitations and Caveats

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

Results Point of Contact

• Title: Timothy A. Damron
• Organization: Upstate Orthopedics

damront@upstate.edu

315-464-8602

Study Officials

• Timothy A Damron, MD

  State University of New York - Upstate Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 1, 2005
• First Posted: September 5, 2005
• Study Start: June 1, 2002
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: April 8, 2013
• Results First Posted: April 8, 2013

Record last verified: 2013-03

Locations

US (1)