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Alendronate Osteoporosis Study

Primary Purpose

Glucocorticoid-Associated Osteopenia and Osteoporosis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Alendronate
Sponsored by
Boston Children's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glucocorticoid-Associated Osteopenia and Osteoporosis focused on measuring Crohn's disease, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus (SLE), Mixed connective tissue disease (MCTD), vasculitis

Eligibility Criteria

8 Years - 22 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects must be diagnosed with either ulcerative colitis, Crohn's disease, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD) or vasculitis according to standard criteria where available, and according to treating physicians when not available. Subjects must have diminished AP lumbar spine (L1-L4) BMD by DXA (Hologic 4500) with a Z score ≤ -1.5 SD assessed within 8 weeks of the Baseline Visit. Subjects must have received daily, alternate day or weekly systemic glucocorticoid therapy for a minimum of six months total in their life-time. Subjects must be between the ages of 8 and 21 years, 11 months, at randomization. Although subjects younger than 8 years of age may be affected by osteoporosis, limited normative data prevents assignment of a BMD Z score for this group. Regarding subjects with child-bearing potential Females who have had at least one menstrual cycle must either be abstinent or must be using an effective method of birth control. Exclusion Criteria: Current or recent (within 6 months) treatment with therapeutic doses of a bisphosphonate, calcitonin, human growth hormone, and heparin, all agents known to alter bone density A history of recent (within one year of screening) major upper gastrointestinal (GI) disease (above the jejunum), including, but not limited to, peptic ulcer, esophageal disease or active GI bleeding, or ever had surgery of the upper GI tract other than pyloroplasty. A history of abnormalities of the esophagus which delay esophageal emptying, such as stricture or achalasia Hyperthyroidism (suppressed thyroid stimulating hormone (TSH) and elevated free thyroxine (T4)), hyperparathyroidism (elevated parathyroid hormone (PTH)), malignancy, rickets, or osteomalacia (by history), all assessed within 8 weeks of the Baseline Visit. 25 (OH) vitamin D below 20 mg/L Planned or current pregnancy and/or breastfeeding Renal dysfunction defined as dependence on dialysis or a creatinine clearance < 35 ml/min, assessed within 4 weeks of the Baseline Visit. Creatinine clearance = [(height in cm x 0.55)/plasma creatinine] for all females and for males < 13 years old; [(height in cm x 0.70)/plasma creatinine] for males ³ 13 years old. Hepatic insufficiency defined as SGPT or SGOT greater than twice normal for age, assessed within 4 weeks of the Baseline Visit. Uncorrected hypocalcemia (ionized calcium>10% below age-adjusted range), assessed within 4 weeks of the Baseline Visit Known or suspected hypersensitivity to bisphosphonates Inability to follow instructions for dosing, including being unable to swallow the study medication with plain water first thing in the morning, stand or sit upright without any other food or beverage for at least 30 minutes following dosing and until their next meal Weight greater than 136 kg (300 lb), as the DXA is not reliable for subjects of this size Weight less than 17 kg (37 lb), assessed within 8 weeks of the Baseline Visit Permanent foreign body (prosthetic, surgical clips, permanent earring/umbilical ring) in region of results of the study Enrollment Procedures interest, or soft tissue calcinosis overlying the region of interest Inability to undergo dual energy X-ray absorptiometry or CT scan Developmental or cognitive delay which may interfere with cooperation and/or compliance with the procedures Subject expects to move out of the area during the study period, rendering follow-up per protocol impractical

Sites / Locations

    Outcomes

    Primary Outcome Measures

    To test the hypothesis that among children and adolescents with Crohn's disease, ulcerative colitis, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus, mixed connective tissue disease and vasculitis, tr

    Secondary Outcome Measures

    Alternate outcome measures
    Comparison of DXA and QCT
    Predictors for response to alendronate
    Growth velocity
    Fracture assessment

    Full Information

    First Posted
    July 7, 2005
    Last Updated
    April 10, 2017
    Sponsor
    Boston Children's Hospital
    Collaborators
    Glaser Pediatric Research Network, Elizabeth Glaser Pediatric AIDS Foundation
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00277251
    Brief Title
    Alendronate Osteoporosis Study
    Official Title
    Double-Blinded Controlled Trial of Alendronate for the Treatment of Childhood and Adolescent Glucocorticoid- Associated Osteopenia and Osteoporosis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (Actual)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    June 2006 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Boston Children's Hospital
    Collaborators
    Glaser Pediatric Research Network, Elizabeth Glaser Pediatric AIDS Foundation

    4. Oversight

    5. Study Description

    Brief Summary
    This trial will test the hypothesis that among 20 children and adolescents from Children's Hospital, Boston with Crohn's disease, ulcerative colitis, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus, mixed connective tissue disease and vasculitis, treatment of glucocorticoid-associated osteopenia and osteoporosis with 18 months of alendronate (FOSAMAX®, Merck & Co., Inc.) will result in greater improvement in the mean change of individual AP spine bone mineral density (BMD) (gm/cm2) determined by dual energy X-ray absorptiometry (DXA) than treatment with 18 months of standard of care therapy.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Glucocorticoid-Associated Osteopenia and Osteoporosis
    Keywords
    Crohn's disease, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus (SLE), Mixed connective tissue disease (MCTD), vasculitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Factorial Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    20 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Alendronate
    Primary Outcome Measure Information:
    Title
    To test the hypothesis that among children and adolescents with Crohn's disease, ulcerative colitis, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus, mixed connective tissue disease and vasculitis, tr
    Secondary Outcome Measure Information:
    Title
    Alternate outcome measures
    Title
    Comparison of DXA and QCT
    Title
    Predictors for response to alendronate
    Title
    Growth velocity
    Title
    Fracture assessment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    22 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Subjects must be diagnosed with either ulcerative colitis, Crohn's disease, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD) or vasculitis according to standard criteria where available, and according to treating physicians when not available. Subjects must have diminished AP lumbar spine (L1-L4) BMD by DXA (Hologic 4500) with a Z score ≤ -1.5 SD assessed within 8 weeks of the Baseline Visit. Subjects must have received daily, alternate day or weekly systemic glucocorticoid therapy for a minimum of six months total in their life-time. Subjects must be between the ages of 8 and 21 years, 11 months, at randomization. Although subjects younger than 8 years of age may be affected by osteoporosis, limited normative data prevents assignment of a BMD Z score for this group. Regarding subjects with child-bearing potential Females who have had at least one menstrual cycle must either be abstinent or must be using an effective method of birth control. Exclusion Criteria: Current or recent (within 6 months) treatment with therapeutic doses of a bisphosphonate, calcitonin, human growth hormone, and heparin, all agents known to alter bone density A history of recent (within one year of screening) major upper gastrointestinal (GI) disease (above the jejunum), including, but not limited to, peptic ulcer, esophageal disease or active GI bleeding, or ever had surgery of the upper GI tract other than pyloroplasty. A history of abnormalities of the esophagus which delay esophageal emptying, such as stricture or achalasia Hyperthyroidism (suppressed thyroid stimulating hormone (TSH) and elevated free thyroxine (T4)), hyperparathyroidism (elevated parathyroid hormone (PTH)), malignancy, rickets, or osteomalacia (by history), all assessed within 8 weeks of the Baseline Visit. 25 (OH) vitamin D below 20 mg/L Planned or current pregnancy and/or breastfeeding Renal dysfunction defined as dependence on dialysis or a creatinine clearance < 35 ml/min, assessed within 4 weeks of the Baseline Visit. Creatinine clearance = [(height in cm x 0.55)/plasma creatinine] for all females and for males < 13 years old; [(height in cm x 0.70)/plasma creatinine] for males ³ 13 years old. Hepatic insufficiency defined as SGPT or SGOT greater than twice normal for age, assessed within 4 weeks of the Baseline Visit. Uncorrected hypocalcemia (ionized calcium>10% below age-adjusted range), assessed within 4 weeks of the Baseline Visit Known or suspected hypersensitivity to bisphosphonates Inability to follow instructions for dosing, including being unable to swallow the study medication with plain water first thing in the morning, stand or sit upright without any other food or beverage for at least 30 minutes following dosing and until their next meal Weight greater than 136 kg (300 lb), as the DXA is not reliable for subjects of this size Weight less than 17 kg (37 lb), assessed within 8 weeks of the Baseline Visit Permanent foreign body (prosthetic, surgical clips, permanent earring/umbilical ring) in region of results of the study Enrollment Procedures interest, or soft tissue calcinosis overlying the region of interest Inability to undergo dual energy X-ray absorptiometry or CT scan Developmental or cognitive delay which may interfere with cooperation and/or compliance with the procedures Subject expects to move out of the area during the study period, rendering follow-up per protocol impractical
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Catherine Gordon, MD
    Organizational Affiliation
    Boston Children's Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Alendronate Osteoporosis Study

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