NCT00010439

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 2, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

February 2, 2001

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2003

Completed
5.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

September 17, 2010

Completed
Last Updated

November 8, 2010

Status Verified

October 1, 2010

Enrollment Period

3.1 years

First QC Date

February 2, 2001

Results QC Date

June 3, 2009

Last Update Submit

October 21, 2010

Conditions

Osteoporosis

Keywords

arthritis & connective tissue diseasesidiopathic juvenile osteoporosisrare disease

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Increased Bone Mineral Density

    Number of participants with increase in bone mineral density at Lumbar Spine and/or Hip at 12 months as compared to the bone mineral density at Lumbar Spine and/or Hip obtained before therapy (baseline values)

    at 12 months

Secondary Outcomes (1)

  • Participants (1) With Fractures Before and After Therapy,(2)Analysed for Average Changes From High to Near Normal Mineral Apposition Rate (MAR) After Therapy,(3)Analysed for Average Insignificant Changes in Biochemical Markers After Therapy.

    Before and 12 months after treatment with alendronate

Study Arms (1)

1 Alendronate for 12 months

EXPERIMENTAL

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

Drug: Alendronate

Interventions

AlendronateDRUG

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

Also known as: Fosamax
1 Alendronate for 12 months

Eligibility Criteria

Age5 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

  • 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.

    PMID: 12795371RESULT

Related Links

MeSH Terms

Conditions

OsteoporosisArthritisConnective Tissue DiseasesJuvenile osteoporosisRare Diseases

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesJoint DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Results Point of Contact

Title
Deborah A Bowlby, M.D., Assistant Professor, Pediatric Endocrinology
Organization
Medical University of South Carolina
bowlbyd@musc.edu
843-792-6807

Study Officials

  • Deborah A Bowlby, M.D.

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 2, 2001

First Posted

February 2, 2001

Study Start

September 1, 2000

Primary Completion

October 1, 2003

Study Completion

November 1, 2008

Last Updated

November 8, 2010

Results First Posted

September 17, 2010

Record last verified: 2010-10

Locations

US(1)