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Bisphosphonate Therapy for Osteogenesis Imperfecta

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Linda DiMeglio, MD, Indiana University
ClinicalTrials.gov Identifier:
NCT00159419
First received: September 7, 2005
Last updated: May 17, 2017
Last verified: May 2017
September 7, 2005
May 17, 2017
August 1999
August 2008   (Final data collection date for primary outcome measure)
Bone Mineral Density [ Time Frame: 2 years ]
By Dual-energy x-ray absorptiometry. Results were reported as z-scores as well as as absolute values. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean with negative numbers indicating values lower than the mean and positive values higher. Higher Z scores indicate a better outcome", or similar, as accurate and appropriate.
Bone mineral density measured 4 monthly, fracture rates
Complete list of historical versions of study NCT00159419 on ClinicalTrials.gov Archive Site
Not Provided
Audiologic effects (annual), dental effects (annual), pain assessments, bone turnover assessments
Not Provided
Not Provided
 
Bisphosphonate Therapy for Osteogenesis Imperfecta
Bisphosphonate Therapy for Osteogenesis Imperfecta
The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." We, the researchers at Indiana University School of Medicine, are characterizing the changes effected by oral bisphosphonate therapy and comparing them to a regimen of intravenous bisphosphonate therapy in a group of children with OI and also in children with other disorders that result in low bone mass and fractures.

The study is designed to evaluate the efficacy and safety of "Bisphosphonate Therapy for Osteogenesis Imperfecta (OI)." OI is an inherited disorder of collagen synthesis. Collagen is the major structural protein of the matrix of tendons, skin, and bones. Affected persons have low bone mineral density (and experience multiple fractures and progressive bony deformity). In its most severe form, the disorder is lethal in infancy. We plan to characterize the changes effected by oral bisphosphonate therapy and compare them to a regimen of intravenous bisphosphonate therapy in a group of children with OI.

Additionally, we have begun to treat patients with OI and other conditions of low bone mineralization for age who are not eligible for the standard protocol (too young, history of abdominal pain, etc.) with bisphosphonate. We also plan to screen the parents and siblings of our patients diagnosed with osteogenesis imperfecta, in order to determine if they also have osteoporosis.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Osteogenesis Imperfecta
  • Osteoporosis
  • Paget Disease of Bone
  • Drug: Alendronate
    Other Name: fosamax
  • Drug: Pamidronate
  • Active Comparator: Alendronate
    1 mg/kg po qd rounded to nearest 10 or 20 mg dose
    Intervention: Drug: Alendronate
  • Active Comparator: Pamidronate
    3 mg/kg IV q4 months
    Intervention: Drug: Pamidronate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
August 2008
August 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of OI, as defined by genetic analysis revealing a defect of type I collagen, OR by bone mineral density (BMD) <2.5 standard deviations (SD) for age plus two of the following:

    • Family history of OI
    • Frequent fractures
    • Blue sclerae
    • Multiple wormian bones on skull x-ray
    • Hearing disturbance
    • Dentinogenesis imperfecta
  • Age between 3 and 21 years at the start of the study period.
  • Children must be able to swallow whole tablets
  • Parents of children must be able to understand protocol and give informed consent.

Exclusion Criteria:

  • Therapy with bisphosphonates during the past 12 months.
  • Other "non-traditional" therapy for OI in the last 6 months, such as growth hormone or anabolic steroids.
  • Other chronic diseases besides OI that interfere with bone morphology or gastrointestinal absorption
Sexes Eligible for Study: All
3 Years to 21 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00159419
9902-30
Yes
Not Provided
Not Provided
Linda DiMeglio, MD, Indiana University
Indiana University School of Medicine
Not Provided
Principal Investigator: Linda A DiMeglio, MD, MPH Indiana University School of Medicine
Indiana University
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP