- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00145704
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?
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
New York
-
Syracuse, New York, Forenede Stater, 13210
- Upstate Medical University
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Aktiv komparator: 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.
|
Vitamin D given to patients with growth hormone deficiency
Andre navne:
calcium supplement given to patients with growth hormone deficiency
|
Eksperimentel: 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
|
Vitamin D given to patients with growth hormone deficiency
Andre navne:
calcium supplement given to patients with growth hormone deficiency
Bisphosphonate therapy given to patients with growth hormone deficiency
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Change in Total Body Bone Mineral Density During an 18 Month Period
Tidsramme: 18 months
|
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
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Timothy A Damron, MD, State University of New York - Upstate Medical University
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Metaboliske sygdomme
- Muskuloskeletale sygdomme
- Knoglesygdomme
- Knoglesygdomme, metaboliske
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Mikronæringsstoffer
- Membrantransportmodulatorer
- Knogletæthedsbevarende midler
- Calciumregulerende hormoner og midler
- Calciumkanalblokkere
- D-vitamin
- Cholecalciferol
- Vitaminer
- Risedronsyre
- Ergocalciferoler
- Difosfonater
Andre undersøgelses-id-numre
- SUNY UMU IRB # 4689
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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