Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Alendronate in Juvenile Osteoporosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00920075
Recruitment Status : Completed
First Posted : June 15, 2009
Results First Posted : December 10, 2010
Last Update Posted : July 11, 2018
Sponsor:
Collaborators:
FDA Office of Orphan Products Development
Merck Sharp & Dohme Corp.
Information provided by:
Medical University of South Carolina

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The investigators earlier have shown that treatment of patients with juvenile osteoporosis with alendronate (Fosamax) for 12 months increased the bone density without side effects. In an open label study (10 patients) and double blind, crossover study (11 patients alendronate and 11 patients placebo), the investigators have further observed that alendronate increased the bone density significantly where as placebo (calcium and vitamin D) increased only minimally. These trials were completed. Thus, a post study is designed to evaluate the current status of the bone density and fractures after the patients discontinued the alendronate treatment. No treatment is involved.

Condition or disease Intervention/treatment
Juvenile Osteoporosis Low Bone Density Fractures Drug: Alendronate (Fosamax)

Detailed Description:
With the availability of Dual Energy X-ray Absorptiometry (DXA), juvenile osteoporosis has been recognized and diagnosed in recent years. The disease results from either diminished bone formation or increased bone removal (resorption) resulting in low bone density and fractures. No specific drug therapy has been recommended for juvenile osteoporosis. In an open label study, we earlier have shown that alendronate treatment (10 patients) for 12 months increased bone density without side effects. Subsequently, in a double blind, crossover study, we have further confirmed that alendronate treatment (11 patients) increased bone density significantly whereas, placebo (11 patients with calcium and vitamin D), increased the bone density only minimally. There were no side effects. These patients were treated with alendronate only for 12 months and the clinical trials have been completed. We therefore, have designed a post study to evaluate the current status of the bone density and fracture history in the above participants after the discontinuation (1-6 years) of alendronate treatment. Available participants, who have completed the earlier study, will be scheduled for a one time clinic visit. Measurements include DXA bone density measurement of spine and hip, urinalysis and blood work. No treatment is involved.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Other
Time Perspective: Other
Official Title: Phase II Study of Alendronate Sodium in Juvenile Osteoporosis (IND# 60,017)-Post Study Evaluation of Participants From Phase IIa and Phase IIb Clinical Study.
Study Start Date : July 2009
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
1 Alendronate for 12 months, post study
Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
 Drug: Alendronate (Fosamax)
Pill, 35mg or 70mg depending upon the body weight for 12 months. This was given for participants during the open label or double blind study. Current study is a post study evaluation of the current status of bone density after the participants completed the study. In this post study, no treatment is involved.
Other Name: Fosamax


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Bone Mineral Density (BMD) of the Lumbar Spine (Participants With Percentage Increase). [ Time Frame: Post study (1-6 yrs), one clinical visit ]
    Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of spine was measured by DXA scan.


Secondary Outcome Measures :
  1. Bone Mineral Density (BMD) of the Hip (Participants With Percentage Increase). [ Time Frame: Post study (1-6 years), one clincial visit ]
    Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Bone density of hip was measured by DXA scan.

  2. Number of Participants With Fracture [ Time Frame: Post study (1-6 years), one clinical visit ]
    Participants who earlier completed in our open labeled or double blind study of alendronate treatment for juvenile osteoporosis, were invited for one clinical visit. Their bone densities of spine and hip were measured by DXA scan. During this visit, their fracture history was obtained.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Available male and female children who have participated and Completed in our earlier open label or double blind clinical trial.
Criteria

Inclusion Criteria:

  • Participated in our earlier clinical study;
  • Completed the earlier open label or double blind study;
  • Availability to participate in the post study;
  • Male and female children who have earlier participated in our clinical trial; AND
  • Parental consent (and patient assent after age 12 years) to participate in the study. Participant's consent for those who have completed 18 years of age and above at the time of clinic visit.

Exclusion Criteria:

  • Not participated in our earlier clinical study;
  • Not completed our earlier trials; OR
  • Pregnancy.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00920075


Locations
Layout table for location information
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
FDA Office of Orphan Products Development
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Principal Investigator: Deborah A Bowlby, M.D. Medical University of South Carolina
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Deborah A Bowlby, MD, Assistant Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00920075    
Other Study ID Numbers: 5R01FD001847-05 REVISED
FD-R-001847-03 ( Other Identifier: FDA )
5R01FD001847-05 ( U.S. NIH Grant/Contract )
First Posted: June 15, 2009    Key Record Dates
Results First Posted: December 10, 2010
Last Update Posted: July 11, 2018
Last Verified: November 2010
Keywords provided by Medical University of South Carolina:
Juvenile Osteoporosis
Bone Mineral Density
Fosamax
Dual Energy X-Ray Absorptiometry
Fracture
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
 Metabolic Diseases
Alendronate
Bone Density Conservation Agents
Physiological Effects of Drugs