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NCT00145704 · OUTCOME

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

Study of Adults With Low Growth Hormone Who Survived Childhood Cancer Where Treatment Caused Low Bone Density · Source last updated 2013-04-08

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
Not reported
Unit
Not reported
Interval / dispersion
Not reported
Time frame
18 months

What was measured

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.

Analysis population: Data analyis halted, due to low enrollment,no outcomes to report

Groups in this outcome

Bisphosphonate and Growth Hormone Use

bisphosphonate use and growth hormone use

Growth Hormone Only

Growth hormone use only, no bisphosphonate used

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Bisphosphonate and Growth Hormone Use0
Growth Hormone Only0

Reported measurements

No numerical measurement classes were posted for this outcome. Missing is not zero.

Complete source fields
denoms
  1. counts
    1. group Id
      OG000
      value
      0
    2. group Id
      OG001
      value
      0
    units
    Participants
description
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.
groups
  1. description
    bisphosphonate use and growth hormone use
    id
    OG000
    title
    Bisphosphonate and Growth Hormone Use
  2. description
    Growth hormone use only, no bisphosphonate used
    id
    OG001
    title
    Growth Hormone Only
population Description
Data analyis halted, due to low enrollment,no outcomes to report
reporting Status
POSTED
time Frame
18 months
title
Change in Total Body Bone Mineral Density During an 18 Month Period
type
PRIMARY

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice