OsteopeniaPhase 2/3NCT00209469
Network Osteoporosis Study
A Phase 2/3 study testing alendronate sodium in people with Osteopenia and Osteoporosis, run by Glaser Pediatric Research Network at 4 sites in United States.
Trial summary
This study is evaluating the use of the drug alendronate in preventing or reversing bone loss in children and adolescents receiving steroid medications. Read more about this study
- Who is it for?
- Ages 8 to 22 years
- Conditions the study is for
- Osteopenia, Osteoporosis
- What is being tested?
- alendronate sodium
- How many people
- 90 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2002to Feb 2007
- 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
- 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. Subjects through 21 years, 11 months will be included because many individuals with chronic disorders will have an immature skeleton, and even in healthy individuals there is significant accrual of bone mass into the 20's, making this a dynamic and critical time period for analysis.
- Females who have had at least one menstrual cycle must either be abstinent or must be using an effective method of birth control (e.g. intrauterine contraceptive device, oral contraceptive, diaphragm or condom with contraceptive jelly, cream, or foam). This will be documented at each visit. Additionally, they must test negative on a urine pregnancy test which will be administered at every visit. Subjects will be informed that because the drug remains in the body for many years, it is possible that a developing fetus could be harmed by the drug even if a woman stops taking the drug long before she becomes pregnant.
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 g/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 13 years old.
Show all 17Show fewer
- 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 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
- Subject has any other condition or therapy that, in the opinion of the investigator, might pose a risk to the subject or confound the results of the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Children's Hospital, Boston
Boston, Massachusetts, 02115
University of California, Los Angeles
Los Angeles, California, 90095
University of California, San Francisco
San Francisco, California, 94143
Stanford University
Stanford, California, 94305
About this study
Official title: Double Blind Controlled Trial of Alendronate for the Treatment of Childhood and Adolescent Glucocorticoid-Associated Osteopenia and Osteoporosis
This study is evaluating the use of the drug alendronate in preventing or reversing bone loss in children and adolescents receiving steroid medications.
Read the detailed description
This trial will test the hypothesis that among 90 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, 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.
- Conditions
- Osteopenia, Osteoporosis
- Being tested
- alendronate sodium
- Medical subject headings
- Bone Diseases, Metabolic, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alendronate sodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change of individual AP spine BMD (gm/cm2) determined by dual energy X-ray absorptiometry (DXA) at 6, 12,18, 24 and 30 Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startJul 2002
- Study completionFeb 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteopeniaStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 90 participants
Sponsor and investigators
- Lead sponsor
- Glaser Pediatric Research Network
- Sponsor type
- Research network
- Collaborators
- Elizabeth Glaser Pediatric AIDS Foundation
- Investigators
- Emily von Scheven, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00209469
- Sponsor's protocol ID
- GPRN1.OSTEO.PL.6.0
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 21 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Controlled Trial of Alendronate for the Treatment of Childhood and Adolescent Glucocorticoid-Associated Osteopenia and Osteoporosis
- ClinicalTrials.gov ID
- NCT00209469
- Acronym / sponsor ID
- GPRN1.OSTEO.PL.6.0
- Conditions
- Osteopenia, Osteoporosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants
- Lead sponsor
- Glaser Pediatric Research NetworkResearch network
- Collaborators
- Elizabeth Glaser Pediatric AIDS Foundation
- Study start
- Jul 2002
- Study completion
- Feb 2007
- First posted
- 21 Sep 2005 (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 study is evaluating the use of the drug alendronate in preventing or reversing bone loss in children and adolescents receiving steroid medications.
Detailed description
This trial will test the hypothesis that among 90 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, 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
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 8 to 22 years
- Sex
- All
- 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. Subjects through 21 years, 11 months will be included because many individuals with chronic disorders will have an immature skeleton, and even in healthy individuals there is significant accrual of bone mass into the 20's, making this a dynamic and critical time period for analysis.
- Females who have had at least one menstrual cycle must either be abstinent or must be using an effective method of birth control (e.g. intrauterine contraceptive device, oral contraceptive, diaphragm or condom with contraceptive jelly, cream, or foam). This will be documented at each visit. Additionally, they must test negative on a urine pregnancy test which will be administered at every visit. Subjects will be informed that because the drug remains in the body for many years, it is possible that a developing fetus could be harmed by the drug even if a woman stops taking the drug long before she becomes pregnant.
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 g/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 sodium | Drug | – |
Primary outcome
Mean change of individual AP spine BMD (gm/cm2) determined by dual energy X-ray absorptiometry (DXA) at 6, 12,18, 24 and 30 Months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2005.
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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.
Emily von Scheven, MD principal investigator
University of California, San Francisco
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing alendronate sodium in people with Osteopenia and Osteoporosis, run by Glaser Pediatric Research Network at 4 sites in United States.
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: status not confirmed, as of the sponsor's last update on 21 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Mean change of individual AP spine BMD (gm/cm2) determined by dual energy X-ray absorptiometry (DXA) at 6, 12,18, 24 and 30 Months.. 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 21 Sep 2005.