OsteoporosisPhase 2NCT00409032
A Dose-response Study With Strontium Malonate in Postmenopausal Women
A Phase 2 study testing Strontium malonate in people with Osteoporosis, run by Osteologix at 9 sites in 2 countries.
Trial summary
The primary objective of the study is to compare dose-response effect of three dose levels of strontium malonate to placebo on bone resorption quantified by S-CTX-1 following 12 weeks of treatment. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Osteoporosis
- What is being tested?
- Strontium malonate
- How many people
- 275 participants
- Where
- 9 sitesin 2 countries
- Study dates
- Dec 2006to Sep 2007
- Phase
- Phase 2
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women (at least 12 months since last menstruation).
- BMD (L2-4) T-score between -1 and -3 (at least 20% of the enrolled patients must have a BMD (L2-4) T-score below -2,5).
- 50 years of age.
- BMI<30 kg/m2.
- Total S-Ca level within normal range.
- Ability to read and understand the information given.
- The patient has signed an informed consent form according to ICH E6 and local requirements before any study specific procedure is carried out.
- Ability to comply with study procedures.
Who cannot join
- History of prior fragility fracture (any fracture in wrist, hip or spine appearing after 40 years of age).
- History of alcohol or drug abuse.
- Metabolic bone disease (e.g. pagets disease, bone cancer).
- History of VTE/DVT.
- History of kidney transplant.
- Bilateral oophorectomy.
Show all 19Show fewer
- Relevant and treated reduced kidney or liver function.
- Any malignancy within the last 5 years (except basal cell carcinoma)
- Any chronic condition likely to affect absorption (e.g. Crohns disease, gluten enteropathy).
- Known genetic pre-disposition to VTE/DVT
- Known hypersensitivity to any of the active substances or excipients.
- 25-OH-vitamin D level below 25 nmol/L
- Any previous treatment with bisphosphonates, Strontium or fluoride.
- Treatment during the last 3 months affecting calcium balance or bone metabolism (e.g. thiazides, corticosteroids, calcitonin, HRT, SERMs, PTH, phosphorus).
- Treatment during the last week with tetracycline, ciprofloxacin or loop diuretics.
- PTH out of normal range
- Use of any drug known to influence the coagulation process (aspirin and other NSAID allowed)
- Prothrombin time out of normal range (sec or INR)
- Inclusion in another clinical study within 30 days before randomization or during this study
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
United Kingdom7 sites
Synexus Wales Clinical Research Centre
Cardiff, CF14 5GJ
Synexus Scotland Clinical Research Centre
Glasgow, G81 2DR
Medinova Clinic
Northwood, Middlesex
Synexus Limited Reading Clinical Research Centre
Reading, RG2 7AG
University of Sheffield
Sheffield, S5 7AU
Synexus Crosby Clinical Research Centre
Waterloo, L22 0LG
Synexus Wigan Clinical Research Centre
Wigan, WN1 1XX
Denmark2 sites
PhaseOneTrials
Hvidovre, 2650
Odense University Hospital
Odense, 5000
About this study
Official title: A Dose-response Study With Strontium Malonate in Postmenopausal Women. A 12 Week, Multi National, Double Blind, Randomized, 5 Arms, Parallel Group Placebo Controlled Open Label Active Controlled, Phase II Study With 3 Dose Levels of Strontium Malonate and Protelos Within Post Menopausal Women With a BMDT-score Below -1
The primary objective of the study is to compare dose-response effect of three dose levels of strontium malonate to placebo on bone resorption quantified by S-CTX-1 following 12 weeks of treatment.
Read the detailed description
275 post menopausal women are treated with either 750 mg strontium malonate, 1000 mg strontium malonate, 2000 mg strontium malonate, 2 g Protelos® or placebo.
Patients are treated for 12 weeks. A follow up period of 4 weeks is planned for the main study and a follow up period of 8 weeks is planned for approximately 20% of the patients to follow post treatment CTX-1 activity.
Apart from S-CTS-1 also response on other bio markers are evaluated as well as BMD.
- Conditions
- Osteoporosis
- Being tested
- Strontium malonate
- Keywords
- osteoporosis, BMD, CTX, Post menopausal, strontium, bone turnover, clinical development
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strontium malonateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
CTX-1
Secondary outcomes (1)
Other bio markers, BMD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionAug 2007
- Study completionSep 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 275 participants
Sponsor and investigators
- Lead sponsor
- Osteologix
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Eastell, Professor, M.D., Principal investigator, University of Sheffield, Metabolic Bone Centre, Northern General Hospital, Sheffield S5 7AU, United Kingdom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00409032
- Sponsor's protocol ID
- NBS-C03-OP
- Status last verified
- Oct 2009
- First submitted
- 7 Dec 2006
- Last updated
- 23 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-response Study With Strontium Malonate in Postmenopausal Women. A 12 Week, Multi National, Double Blind, Randomized, 5 Arms, Parallel Group Placebo Controlled Open Label Active Controlled, Phase II Study With 3 Dose Levels of Strontium Malonate and Protelos Within Post Menopausal Women With a BMDT-score Below -1
- ClinicalTrials.gov ID
- NCT00409032
- Acronym / sponsor ID
- NBS-C03-OP
- Conditions
- Osteoporosis
- Keywords
- osteoporosis, BMD, CTX, Post menopausal, strontium, bone turnover, clinical development
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 275 participants
- Lead sponsor
- OsteologixIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 8 Dec 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.
The primary objective of the study is to compare dose-response effect of three dose levels of strontium malonate to placebo on bone resorption quantified by S-CTX-1 following 12 weeks of treatment.
Detailed description
275 post menopausal women are treated with either 750 mg strontium malonate, 1000 mg strontium malonate, 2000 mg strontium malonate, 2 g Protelos® or placebo.
Patients are treated for 12 weeks. A follow up period of 4 weeks is planned for the main study and a follow up period of 8 weeks is planned for approximately 20% of the patients to follow post treatment CTX-1 activity.
Apart from S-CTS-1 also response on other bio markers are evaluated as well as BMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Postmenopausal women (at least 12 months since last menstruation).
- BMD (L2-4) T-score between -1 and -3 (at least 20% of the enrolled patients must have a BMD (L2-4) T-score below -2,5).
- 50 years of age.
- BMI<30 kg/m2.
- Total S-Ca level within normal range.
Key exclusion criteria (19 listed)
- History of prior fragility fracture (any fracture in wrist, hip or spine appearing after 40 years of age).
- History of alcohol or drug abuse.
- Metabolic bone disease (e.g. pagets disease, bone cancer).
- History of VTE/DVT.
- History of kidney transplant.
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 |
|---|---|---|
| Strontium malonate | Drug | – |
Primary outcome
CTX-1
1 secondary outcome
Other bio markers, BMD
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 23 Oct 2009.
- Related InfoLink 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.
Richard Eastell, Professor, M.D. principal investigator
University of Sheffield, Metabolic Bone Centre, Northern General Hospital, Sheffield S5 7AU, United Kingdom
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Strontium malonate in people with Osteoporosis, run by Osteologix at 9 sites in 2 countries.
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 8 inclusion and 19 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 23 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United Kingdom, Denmark. 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?
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?
CTX-1. 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 Oct 2009.