OsteoporosisPhase 2NCT00010439
Phase II Study of Alendronate Sodium in Children With High-Turnover Idiopathic Juvenile Osteoporosis
A Phase 2 study testing Alendronate in people with Osteoporosis, run by Medical University of South Carolina at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 14 years
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Alendronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Nov 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
- No concurrent prednisone except inhaled steroids
- No concurrent high-dose glucocorticoids
- No concurrent salmon calcitonin
- No other concurrent bisphosphonates
- No concurrent long-term anti-seizure medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Non-Randomized, Open-Label, Prospective, Non-Controlled, 12-Month Clinical Trial to Determine the Effects of Alendronate 35 or 70 mg/Week Depending Upon Body Weight, in Children and Adolescent With IJO
OBJECTIVES:
- 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.
Read the detailed description
PROTOCOL OUTLINE:
Patients receive oral alendronate sodium weekly for 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.
- Conditions
- Osteoporosis
- Being tested
- Alendronate
- Keywords
- arthritis & connective tissue diseases, idiopathic juvenile osteoporosis, rare disease
- Medical subject headings
- Osteoporosis, Arthritis, Connective Tissue Diseases, Juvenile osteoporosis, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
Also called Fosamax
Pill, 35mg or 70mg weekly, depending upon the body weight for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Alendronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Participants (pts) with fractures bef.and aft.therapy; pts analysed for average changes in mineral apposition rate (MAR) (high (1.9um/day) to near normal (1.2 um/day)as revealed in bone biopsies. MAR is the distance between the two tetracycline labels (um/day). The data represent the average of 10-17 measurements of the disltance obtained by reading 2-7 individual slides of bone biopsy and pts analysed for average insignificant biochemical markers (serum bone specific alkaline phosphatase for bone formation and urinary N-telopeptide for resorption)to determine the effect of therapy.
Measured: Before and 12 months after treatment with alendronate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2001 (estimated)
- Study startSep 2000
- Primary completionOct 2003
- Study completionNov 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Investigators
- Deborah A Bowlby, M.D., Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00010439
- Sponsor's protocol ID
- 199/15705
- Other IDs
- FD-R-001847-01
- Status last verified
- Oct 2010
- First submitted
- 2 Feb 2001
- Last updated
- 8 Nov 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 12795371
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-Randomized, Open-Label, Prospective, Non-Controlled, 12-Month Clinical Trial to Determine the Effects of Alendronate 35 or 70 mg/Week Depending Upon Body Weight, in Children and Adolescent With IJO
- ClinicalTrials.gov ID
- NCT00010439
- Acronym / sponsor ID
- 199/15705
- Conditions
- Osteoporosis
- Keywords
- arthritis & connective tissue diseases, idiopathic juvenile osteoporosis, rare disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- Sep 2000
- Primary completion
- Oct 2003 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 2 Feb 2001 (estimated)
- Results
- Posted 17 Sep 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
OBJECTIVES:
- 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.
Detailed description
PROTOCOL OUTLINE:
Patients receive oral alendronate sodium weekly for 1 year. Treatment continues in the absence of disease progression or unacceptable toxicity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 Alendronate for 12 months | Experimental | Drug: AlendronateTen children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily. |
Who may qualify
- Ages
- 5 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (20 listed)
- 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
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 |
|---|---|---|
| AlendronateAlso: FosamaxPill, 35mg or 70mg weekly, depending upon the body weight for 12 months. | Drug | 1 Alendronate for 12 months |
Primary outcome
Number of Participants With Increased Bone Mineral Density
Time frame: at 12 months
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)
1 secondary outcome
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.
Time frame: Before and 12 months after treatment with alendronate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 12795371Key LL Jr, Ries W, Madyastha P, Reed F. Juvenile osteoporosis: recognizing the risk. J Pediatr Endocrinol Metab. 2003 May;16 Suppl 3:683-6.
- "Click here for more information about this study:"Link provided by the sponsor.
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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.
Deborah A Bowlby, M.D. principal investigator
Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Alendronate in people with Osteoporosis, run by Medical University of South Carolina at 1 site 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 20 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 8 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Sep 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Increased Bone Mineral Density (time frame: at 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00010439, which also lists 1 linked publication.
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 8 Nov 2010.