OsteoporosisNCT00536653
Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Prostate Cancer
A study testing Bicalutamide and Calcium/ Vitamin D supplementation, LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation and LHRH agonists (Goserelin acetate) in people with Osteoporosis, run by Wirral University Teaching Hospital NHS Trust at 1 site in United Kingdom.
Trial summary
The aim of this study is to determine the long term effects of two types of hormonal treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on the bone mineral density of patients. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Bicalutamide and Calcium/ Vitamin D supplementation, LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation and LHRH agonists (Goserelin acetate)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 618 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 1999to Jan 2007
- Phase
- Interventional
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients will locally advanced prostate cancer for whom immediate androgen deprivation was indicated
Who cannot join
- Previous systemic therapy for prostate cancer
- Patients with any illness or medication that would affect bone and mineral metabolism
- Severe hepatic or renal insufficiency
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wirral University Hospitals NHS Trust
Upton, Wirral, Merseyside, CH48 5PE
About this study
Official title: Long Term Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer, With Stratification of Treatment Based on Presenting Values
The aim of this study is to determine the long term effects of two types of hormonal treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on the bone mineral density of patients.
Read the detailed description
Androgen ablation is the mainstay of treatment for advanced prostate cancer. However,luteinizing hormone-releasing (LHRH) agonists are associated with accelerated bone loss, osteoporosis and fractures. An alternative is the non steroidal antiandrogen, bicalutamide, which acts at the androgen receptor and maintains serum testosterone levels. Our aim was to assess the effects of these two treatments on bone mineral density (BMD) of selected groups of patients, based on their BMD at presentation. All patients will undergo peripheral bone densitometry of the forearm, using dual energy X-ray absorptiometry. Osteoporotic patients, at high risk of fractures, will be commenced on bicalutamide. Osteopenic and normal BMD patients will be commenced on LHRH agonists. All osteopenic and osteoporotic patients will be given calcium and vitamin D supplementation.Patients will undergo annual bone densitometry scans, and will be seen in the clinic every 3 months to monitor well-being and PSA levels. Any patient who fails to respond or escapes treatment with hormone monotherapy will be managed according to the clinical situation by either being switched to a combination of LHRH and bicalutamide or additional oestrogen therapy.
- Conditions
- Osteoporosis
- Being tested
- Bicalutamide and Calcium/ Vitamin D supplementation, LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation, LHRH agonists (Goserelin acetate)
- Keywords
- prostate cancer, bone density, osteoporosis, androgen antagonists
- Medical subject headings
- Osteoporosis, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bicalutamide and Calcium/ Vitamin D supplementationDrug
Bicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily
LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementationDrug
3 monthly depot injection of LHRH agonist (Goserelin acetate 10.8mg) and Calcium/ Vitamin D supplementation daily
LHRH agonists (Goserelin acetate)Drug
3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg)
| Study group | Role | What they receive |
|---|---|---|
| Osteporosis Group | Active comparator | Patients with a presenting T score < -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD Receives: Drug: Bicalutamide and Calcium/ Vitamin D supplementation |
| Osteopenia Group | Active comparator | Patients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD Receives: Drug: LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation |
| Normal Group | Active comparator | Patients with a presenting T score > -1.0(normal BMD), treated with LHRH agonists Receives: Drug: LHRH agonists (Goserelin acetate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Forearm bone mineral density
Measured: Over 7 years
Secondary outcomes (1)
Fractures of the thoracolumbar spine
Measured: Over 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2007 (estimated)
- Study startOct 1999
- Study completionJan 2007
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.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 618 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wirral University Teaching Hospital NHS Trust
- Sponsor type
- University, hospital or other
- Investigators
- Nigel J Parr, MBBS, FRCS(Urol), MD, Principal investigator, Wirral University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00536653
- Sponsor's protocol ID
- 55/99
- Status last verified
- Aug 2007
- First submitted
- 27 Sep 2007
- Last updated
- 28 Sep 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Changes in Bone Mineral Density and Fracture Risk in Patients Receiving Androgen Deprivation Therapy for Advanced Prostate Cancer, With Stratification of Treatment Based on Presenting Values
- ClinicalTrials.gov ID
- NCT00536653
- Acronym / sponsor ID
- 55/99
- Conditions
- Osteoporosis
- Keywords
- prostate cancer, bone density, osteoporosis, androgen antagonists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 618 participants (actual)
- Lead sponsor
- Wirral University Teaching Hospital NHS TrustUniversity, hospital or other
- Study start
- Oct 1999
- Study completion
- Jan 2007 (actual)
- First posted
- 28 Sep 2007 (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.
The aim of this study is to determine the long term effects of two types of hormonal treatment for advanced prostate cancer (LHRH agonists and the antiandrogen bicalutamide)on the bone mineral density of patients.
Detailed description
Androgen ablation is the mainstay of treatment for advanced prostate cancer. However,luteinizing hormone-releasing (LHRH) agonists are associated with accelerated bone loss, osteoporosis and fractures. An alternative is the non steroidal antiandrogen, bicalutamide, which acts at the androgen receptor and maintains serum testosterone levels. Our aim was to assess the effects of these two treatments on bone mineral density (BMD) of selected groups of patients, based on their BMD at presentation. All patients will undergo peripheral bone densitometry of the forearm, using dual energy X-ray absorptiometry. Osteoporotic patients, at high risk of fractures, will be commenced on bicalutamide. Osteopenic and normal BMD patients will be commenced on LHRH agonists. All osteopenic and osteoporotic patients will be given calcium and vitamin D supplementation.Patients will undergo annual bone densitometry scans, and will be seen in the clinic every 3 months to monitor well-being and PSA levels. Any patient who fails to respond or escapes treatment with hormone monotherapy will be managed according to the clinical situation by either being switched to a combination of LHRH and bicalutamide or additional oestrogen therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Osteporosis Group | Active comparator | Drug: Bicalutamide and Calcium/ Vitamin D supplementationPatients with a presenting T score < -2.5 (osteoporosis), treated with bicalutamide and Ca/VitD |
| Osteopenia Group | Active comparator | Drug: LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementationPatients with a presenting T score between -1.0 and -2,4 (osteopenia), treated with LHRH agonists and Ca/VitD |
| Normal Group | Active comparator | Drug: LHRH agonists (Goserelin acetate)Patients with a presenting T score > -1.0(normal BMD), treated with LHRH agonists |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients will locally advanced prostate cancer for whom immediate androgen deprivation was indicated
Key exclusion criteria (3 listed)
- Previous systemic therapy for prostate cancer
- Patients with any illness or medication that would affect bone and mineral metabolism
- Severe hepatic or renal insufficiency
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 |
|---|---|---|
| Bicalutamide and Calcium/ Vitamin D supplementationBicalutamide 150mg once daily, Calcium and Vitamin D supplementation once daily | Drug | Osteporosis Group |
| LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation3 monthly depot injection of LHRH agonist (Goserelin acetate 10.8mg) and Calcium/ Vitamin D supplementation daily | Drug | Osteopenia Group |
| LHRH agonists (Goserelin acetate)3 monthly depot injection of LHRH agonists (Goserelin acetate 10.8mg) | Drug | Normal Group |
Primary outcome
Peripheral Forearm bone mineral density
Time frame: Over 7 years
1 secondary outcome
Fractures of the thoracolumbar spine
Time frame: Over 7 years
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 28 Sep 2007.
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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.
Nigel J Parr, MBBS, FRCS(Urol), MD principal investigator
Wirral University Hospitals NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bicalutamide and Calcium/ Vitamin D supplementation, LHRH agonists (Goserelin acetate) and Calcium/ Vitamin D supplementation and LHRH agonists (Goserelin acetate) in people with Osteoporosis, run by Wirral University Teaching Hospital NHS Trust at 1 site in United Kingdom.
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 1 inclusion and 3 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 28 Sep 2007. 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 Kingdom. 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.
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?
Peripheral Forearm bone mineral density (time frame: Over 7 years). 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 28 Sep 2007.