MedDataX Logo

Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis

NCT ID: NCT00010439

Last Updated: 2010-11-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-09-30

Study Completion Date

2008-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

OBJECTIVES:

I. Determine the effects of alendronate sodium on skeletal remodeling and bone mineral density of the hip and spine in children with high-turnover idiopathic juvenile osteoporosis.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

PROTOCOL OUTLINE:

Patients receive oral alendronate sodium weekly for 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

arthritis & connective tissue diseases idiopathic juvenile osteoporosis rare disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1 Alendronate for 12 months

Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.

Group Type EXPERIMENTAL

Alendronate

Intervention Type DRUG

Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Alendronate

Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fosamax

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male and female children with a history of one or more atraumatic fractures, or evidence of one or more compression fractures on radiographs of the spine (reduction of \>20%).
* Bone mineral density by DXA at 2 standard deviations (SD) below normal mean for age (Z-score at least 2 SD below normal mean at the lumbar spine or hip)
* Parental consent (and patient assent after age 12 years) to participate in the study.
* Sexual development at Tanner stage II or less (Prepubertal stage)
* Weight 20kg and more

Exclusion Criteria

* History of severe gastritis or reflux
* Marked kyphoscoliosis or inability to sit or stand for at least 30 minutes.
* Abnormalities of the esophagus that delay emptying (e.g., strictures or achalasia)
* Hypersensitivity to bisphosphonates
* Uncorrected hypocalcemia
* History of gastric or duodenal ulcers
* Renal dysfunction as indicated by serum Creatinine greater than 1.5 mg/dL
* Liver dysfunction as indicated by serum SGPT greater than 2 times upper limit of normal for age or serum total bilirubin greater than 2.0 mg/dL
* Diagnosis of osteogenesis imperfecta (including family history) or blue sclerae or deafness
* Diagnosis of active rickets, osteomalacia, or bone alkaline phosphatase \> 2 times normal for age
* Severe gastritis or reflux
* Pregnancy
* Anorexia Nervosa

* Prior/Concurrent Therapy-
* Prior course of prednisone allowed
* No concurrent prednisone except inhaled steroids
* No concurrent high-dose glucocorticoids
* No concurrent salmon calcitonin
* No other concurrent bisphosphonates
* No concurrent long-term anti-seizure medication
Minimum Eligible Age

5 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Medical University of South Carolina

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Deborah A Bowlby, M.D.

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Key LL Jr, Ries W, Madyastha P, Reed F. Juvenile osteoporosis: recognizing the risk. J Pediatr Endocrinol Metab. 2003 May;16 Suppl 3:683-6.

Reference Type RESULT
PMID: 12795371 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

FD-R-001847-01

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

199/15705

Identifier Type: -

Identifier Source: org_study_id