Glucocorticoid-Associated Osteopenia and OsteoporosisPhase 2/3NCT00277251
Alendronate Osteoporosis Study
A Phase 2/3 study testing Alendronate in people with Glucocorticoid-Associated Osteopenia and Osteoporosis, run by Boston Children's Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 22 years
- Conditions the study is for
- Glucocorticoid-Associated Osteopenia and Osteoporosis
- What is being tested?
- Alendronate
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2003to Jun 2006
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 22 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
About this study
Official title: Double-Blinded Controlled Trial of Alendronate for the Treatment of Childhood and Adolescent Glucocorticoid- Associated Osteopenia and Osteoporosis
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.
- Being tested
- Alendronate
- Keywords
- Crohn's disease, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus (SLE), Mixed connective tissue disease (MCTD), vasculitis
- Medical subject headings
- Osteoporosis, Crohn Disease, Arthritis, Juvenile, Dermatomyositis, Lupus Erythematosus, Systemic, Mixed Connective Tissue Disease, Vasculitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (5)
Alternate outcome measures
Comparison of DXA and QCT
Predictors for response to alendronate
Growth velocity
Fracture assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2006 (estimated)
- Study startMar 2003
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glucocorticoid-Associated Osteopenia and OsteoporosisStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Glaser Pediatric Research Network, Elizabeth Glaser Pediatric AIDS Foundation
- Responsible party
- Sponsor
- Investigators
- Catherine Gordon, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00277251
- Sponsor's protocol ID
- 04-12-187R
- Status last verified
- Apr 2017
- First submitted
- 7 Jul 2005
- Last updated
- 11 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blinded Controlled Trial of Alendronate for the Treatment of Childhood and Adolescent Glucocorticoid- Associated Osteopenia and Osteoporosis
- ClinicalTrials.gov ID
- NCT00277251
- Acronym / sponsor ID
- 04-12-187R
- Keywords
- Crohn's disease, systemic-onset juvenile rheumatoid arthritis, juvenile dermatomyositis, systemic lupus erythematosus (SLE), Mixed connective tissue disease (MCTD), vasculitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Collaborators
- Glaser Pediatric Research Network, Elizabeth Glaser Pediatric AIDS Foundation
- Study start
- Mar 2003 (actual)
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 16 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 8 to 22 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alendronate | Drug | – |
Primary outcome
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
5 secondary outcomes
Alternate outcome measures
Comparison of DXA and QCT
Predictors for response to alendronate
Growth velocity
Fracture assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
Related trials for Glucocorticoid-Associated Osteopenia and Osteoporosis
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Glucocorticoid-Associated Osteopenia and Osteoporosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Gordon, MD principal investigator
Boston Children's Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Alendronate in people with Glucocorticoid-Associated Osteopenia and Osteoporosis, run by Boston Children's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.