NCT00259857

Brief Summary

We have previously evaluated the safety and efficacy of Alendronate in 10 patients with juvenile osteoporosis during a 12-month clinical trial. We have documented that Alendronate improved BMD of the spine and hip without any major side effects. There were no additional fractures during therapy. The present study is designed to further evaluate the safety and efficacy of Alendronate in 20 children with juvenile osteoporosis using a double-blind, randomized, placebo-controlled, cross-over protocol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2003

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

October 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 29, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 1, 2005

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

January 19, 2011

Completed
Last Updated

January 19, 2011

Status Verified

December 1, 2010

Enrollment Period

4.4 years

First QC Date

November 29, 2005

Results QC Date

November 9, 2010

Last Update Submit

December 29, 2010

Conditions

Osteoporosis

Keywords

FractureBone Mineral DensityDXA

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy

    Participants were screened for BMD of lumbar spine using DXA scan at visit 12 months after alendronate or placebo treatment.

    12 months therapy

  • Number of Participants With Improvement in Bone Mineral Density (BMD) of Spine After Therapy

    BMD of lumbar spine was measured using DXA scan at visit 24 months (Year-2)after alendronate or placebo treatment.

    24 months therapy

Secondary Outcomes (4)

  • Number of Participants With Improvement in Bone Mineral Density (BMD) of Hip After Therapy

    12 months of therapy

  • Number of Participants With Improvement in BMD of Hip

    24 months of therapy

  • Participants With Atraumatic Fractures

    0 months

  • Participants With Atraumatic Fractures

    24 months

Study Arms (2)

1 Alendronate, Calcium, Vitamin D

EXPERIMENTAL

Crossover study. Year-1, 10 participants will take study medication, calcium and vitamin D supplements and other 10 participants will take placebo, calcium and vitamin D supplements. Year-2, they will crossover to the second arm of the study. Those who took study medication and supplements in year-1, will take placebo and supplements in the year-2, and those 10 participants who took placebo and supplements in the year-1, will take study medications and supplements in the year-2.

Drug: Alendronate

2 Placebo, Calcium and Vitamin D

PLACEBO COMPARATOR

Year-1, 10 participants will take Alendronate (study medication)and calcium and vitamin D supplement). Another 10 participants will take placebo, calcium and vitamin D. In year-2 they will crossover. Those who took alendronate in the first year, will take Placebo, calcium and vitamin D for 12 months and those who took Placebo in the first year, will take Alendronate, calcium and vitamin D in the second year (12 months).

Drug: Alendronate

Interventions

AlendronateDRUG

Group-1/Year-1:Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight, for 12 months. Group-1/Year-2:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-1:Placebo, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months. Group-2/Year-2: Alendronate, pill, 35mg or 70mg, weekly; calcium, pill, 500mg or 1000mg daily; vitamin D, liquid, 800IU, daily, depending upon the body weight for 12 months.

Also known as: Fosamax, TUMS or Viactive, Drisdol or Calciferol
1 Alendronate, Calcium, Vitamin D2 Placebo, Calcium and Vitamin D

Eligibility Criteria

Age5 Years - 15 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 percent).
  • Bone Mineral Density (BMD) determined by DXA sacn to confirm osteoporosis at a Z score greater than 2 SD (standard deviations) below the normal mean for age (Z score \< -2 SD).
  • 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 = 20 kg and more.

You may not qualify if:

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

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

OsteoporosisFractures, Bone

Interventions

AlendronateErgocalciferolsCholecalciferol

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic DiseasesWounds and Injuries

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsCholestenesCholestanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSterolsVitamin DSecosteroidsMembrane LipidsLipids

Results Point of Contact

Title
Deborah A Bowlby, MD, Asst.Professor, Pedeiatric 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
Yes
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 29, 2005

First Posted

December 1, 2005

Study Start

October 1, 2003

Primary Completion

March 1, 2008

Study Completion

August 1, 2009

Last Updated

January 19, 2011

Results First Posted

January 19, 2011

Record last verified: 2010-12

Locations

US(1)