OsteoporosisPhase 3NCT00391404
Fosamax for Childhood Cancer Survivors
A Phase 3 study testing Alendronate in people with Osteoporosis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
Survivors of childhood cancers face a variety of long-term problems. The investigators' recent study found that osteoporosis and osteopenia were common among these patients. The factors leading to, as well as the best treatment option for, this morbidity are unclear. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Alendronate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- May 2006to Oct 2008
- Phase
- Phase 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Chinese patients who completed treatments for childhood cancers for at least 5 years
- Currently followed up in the Department of Paediatrics of Prince of Wales Hospital
- Younger than 18 years old at the time of diagnosis of underlying cancers
- Evidence of osteoporosis (i.e. BMD T- or Z-score < -2.5 at lumbar spine)
- Older than 15 years of age at the time of recruitment
Who cannot join
- Current treatment (i.e. within 6 months) with maintenance systemic or high-dose inhaled corticosteroids
- Subjects who cannot cooperate for BMD measurements
- Pregnant female patients
- Subjects with prior history of allergy to alendronate or in whom alendronate treatment is contraindicated
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital, Shatin, N.T.
Hong Kong
Patrick MP Yuen, MD, FRCPC
Chi Kong Li, MBBS, MD
About this study
Official title: Randomized Controlled Study on the Benefits and Safety of Bisphosphonate Treatment in Childhood Cancer Survivors
Survivors of childhood cancers face a variety of long-term problems. The investigators' recent study found that osteoporosis and osteopenia were common among these patients. The factors leading to, as well as the best treatment option for, this morbidity are unclear. Bisphosphonates are currently the standard therapy for osteoporosis in the elderly. However, the efficacy and safety of bisphosphonates for treating osteoporosis in long-term cancer survivors have not been tested. The investigators hypothesize that alendronate, an orally active bisphosphonate, is efficacious and safe in the treatment of osteoporosis in these patients.
Read the detailed description
The modern treatment for childhood malignancy includes surgery and chemoradiotherapy either individually or in combination. Despite the great achievement in improving patient survival, these treatments also greatly enhance the adverse effects on the unfortunate children. Our research group has recently conducted a pioneer study on the bone mineralization and bone mineral density (BMD) study in longterm childhood cancer survivors in local patients who have completed anti-cancer treatment for at least five years. This landmark study showed that persistent treatment-related adverse effects on skeletal development are common (up to 50%) in local long-term survivors of childhood cancers. Thus, it is important during this critical period of rapid somatic growth in adolescents and young adults that these cancer survivors achieve their peak potential for bone mineralization and strengthening. In this proposed study, we investigate with a randomized and controlled study design on the efficacy of a second-generation oral bisphosphonate, alendronate, to improve BMD over a 36-week period in long-term survivors of childhood cancers in Hong Kong. In addition to alendronate, all subjects in the active and control groups will receive alfacalcidol (vitamin D) and calcium carbonate throughout the whole study period. The study results will help paediatric oncologists to decide on the optimal remedial treatments against osteoporosis in long-term cancer survivors.
- Conditions
- Osteoporosis
- Being tested
- Alendronate, Placebo
- Keywords
- Childhood cancer survivors, Osteoporosis, Bone mineral density, Therapy, Bisphosphonate, Randomized controlled trial
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AlendronateDrug
Also called Fosamax
Alendronate 70 mg weekly (oral)
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Alendronate | Active comparator | Oral alendronate 70 mg weekly Receives: Drug: Alendronate |
| Placebo | Placebo comparator | Conventional drug treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percent change in bone mineral density (BMD) at lumbar spine at 36-weeks in subjects who receive active and control treatments
Measured: 36 weeks
Secondary outcomes (3)
Changes in BMD at femoral neck
Measured: 36 weeks
Changes in biochemical markers of bone turnover
Measured: 36 weeks
Occurrence of clinical bone-related symptoms at 12-weeks and end of this study
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2006 (estimated)
- Study startMay 2006
- Study completionOct 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Ting Fan Leung, MBChB, MD, Principal investigator, Department of Pediatrics, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00391404
- Sponsor's protocol ID
- HK-CCFGrants2005.TFL
- Status last verified
- May 2008
- First submitted
- 23 Oct 2006
- Last updated
- 23 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study on the Benefits and Safety of Bisphosphonate Treatment in Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT00391404
- Acronym / sponsor ID
- HK-CCFGrants2005.TFL
- Conditions
- Osteoporosis
- Keywords
- Childhood cancer survivors, Osteoporosis, Bone mineral density, Therapy, Bisphosphonate, Randomized controlled trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- May 2006
- Study completion
- Oct 2008 (estimated)
- First posted
- 24 Oct 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.
Survivors of childhood cancers face a variety of long-term problems. The investigators' recent study found that osteoporosis and osteopenia were common among these patients. The factors leading to, as well as the best treatment option for, this morbidity are unclear. Bisphosphonates are currently the standard therapy for osteoporosis in the elderly. However, the efficacy and safety of bisphosphonates for treating osteoporosis in long-term cancer survivors have not been tested. The investigators hypothesize that alendronate, an orally active bisphosphonate, is efficacious and safe in the treatment of osteoporosis in these patients.
Detailed description
The modern treatment for childhood malignancy includes surgery and chemoradiotherapy either individually or in combination. Despite the great achievement in improving patient survival, these treatments also greatly enhance the adverse effects on the unfortunate children. Our research group has recently conducted a pioneer study on the bone mineralization and bone mineral density (BMD) study in longterm childhood cancer survivors in local patients who have completed anti-cancer treatment for at least five years. This landmark study showed that persistent treatment-related adverse effects on skeletal development are common (up to 50%) in local long-term survivors of childhood cancers. Thus, it is important during this critical period of rapid somatic growth in adolescents and young adults that these cancer survivors achieve their peak potential for bone mineralization and strengthening. In this proposed study, we investigate with a randomized and controlled study design on the efficacy of a second-generation oral bisphosphonate, alendronate, to improve BMD over a 36-week period in long-term survivors of childhood cancers in Hong Kong. In addition to alendronate, all subjects in the active and control groups will receive alfacalcidol (vitamin D) and calcium carbonate throughout the whole study period. The study results will help paediatric oncologists to decide on the optimal remedial treatments against osteoporosis in long-term cancer survivors.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alendronate | Active comparator | Drug: AlendronateOral alendronate 70 mg weekly |
| Placebo | Placebo comparator | Drug: PlaceboConventional drug treatment |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese patients who completed treatments for childhood cancers for at least 5 years
- Currently followed up in the Department of Paediatrics of Prince of Wales Hospital
- Younger than 18 years old at the time of diagnosis of underlying cancers
- Evidence of osteoporosis (i.e. BMD T- or Z-score < -2.5 at lumbar spine)
- Older than 15 years of age at the time of recruitment
Key exclusion criteria (4 listed)
- Current treatment (i.e. within 6 months) with maintenance systemic or high-dose inhaled corticosteroids
- Subjects who cannot cooperate for BMD measurements
- Pregnant female patients
- Subjects with prior history of allergy to alendronate or in whom alendronate treatment is contraindicated
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: FosamaxAlendronate 70 mg weekly (oral) | Drug | Alendronate |
| PlaceboPlacebo | Drug | Placebo |
Primary outcome
The percent change in bone mineral density (BMD) at lumbar spine at 36-weeks in subjects who receive active and control treatments
Time frame: 36 weeks
3 secondary outcomes
Changes in BMD at femoral neck
Time frame: 36 weeks
Changes in biochemical markers of bone turnover
Time frame: 36 weeks
Occurrence of clinical bone-related symptoms at 12-weeks and end of this study
Time frame: 36 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2008.
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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.
Ting Fan Leung, MBChB, MD principal investigator
Department of Pediatrics, The Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alendronate in people with Osteoporosis, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 4 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 23 May 2008. 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 Hong Kong. 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. Some participants in this study may receive a placebo. 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 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?
Contact Ting Fan Leung, MBChB, MD (852-2632 2981, tfleung@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percent change in bone mineral density (BMD) at lumbar spine at 36-weeks in subjects who receive active and control treatments (time frame: 36 weeks). 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 23 May 2008.