A multi-centre randomised double blind, placebo and active controlled parallel group study to investigate efficacy and safety of ONO-5334 in post menopausal women with osteopenia or osteoporosis.

Phase 2

Completed

Conditions: bone weakness
osteoporosis
10005959

Registration Number: NL-OMON35369

Lead Sponsor: ONO Pharma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

Inclusion Criteria

- Post-menopausal women aged between 55 and 75 years old
- Osteoporosis defined as a value of DXA BMD 2.5 standard deviations or more below the young adult mean at the lumbar spine or total hip in the absence of any fragility fractures OR
- Osteopenia defined as a value of DXA BMD more than 1 standard deviation below the young adult mean, but less that 2.5 standard deviations below this value at the lumbar spine or total hip with the presence of one or more fragility fractures
- Written informed consent

Exclusion Criteria

- Patients with a value of DXA BMD more than 3.5 standard deviation below the young adult mean at the lumbar spine or total hip,
- Patients who have abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of BMD,
- Patients who have experienced clinical fractures one year prior to the Randomisation visit (visit 1)
- Patients who have secondary causes of osteoporosis
- Patients who have other disorders of bone and mineral metabolism
- Patients for whom once weekly Alendronate treatment is contraindicated
- Patients with a low bone turnover defined as urinary CTX-I below 200 microgramme/mmolCr at the Screening visit
- Patients who have history or presence of other significant disease, which in the opinion of the investigator, might compromise the patient*s safety or the evaluation of the study results
- A history of drug or alcohol abuse
- Patients who have history of malignancy within the past 5 years of the Screening visit.
- Patients with impaired hepatic function
- Patients with impaired renal function
- Any previous use of PTH and its derivatives, Strontium or Fluoride including ones in development before screening visit
- Use of bisphosphonates in the three years preceding screening visit
- Use of HRT, SERMs, Calcitonin, Anabolic Steroid, Thiazides, Vitamin K or any medication that may in the opinion of the investigator have an effect on bone metabolism in the preceding one year or the screening visit
- Use of Antacids, Systemic oral glucocorticiods, high daily dose of inhaled glucocorticoids, Methotrexate, Systemic heparin or Anti-convulsant in the preceding one year of the Screening visit
- Poor medication compliance (<80%)
Patients who have sed any investigational drug and/or participated in any clinical trial within 3 months of the Screening visit
- Patients who have previously received ONO-5334
- In the opinion of the invastigator, the patient may not be able to cooperate fully with the study staff, may have difficulty following some requirements, or is otherwise not qualified for the study.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary objective of this clinical study is to compare the percentual<br /><br>change in bone density of the lumbar spine between baseline and 12 months<br /><br>following treatment with ONO-5334 or placebo. The objective of the extension<br /><br>study is to investigate the efficacy of ONO-5334 over a longer period.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To compare the effect of ONO-5334 or once weekly Alendronate versus placebo<br /><br>on DXA BMD and BMC and biochemical markers of bone turnover.<br /><br>- To compare the proportions of responders to ONO-5334 or Alendronate therapy<br /><br>versus placebo.<br /><br>- To compare the safety and tolerability of ONO-5334 or Alendronate versus<br /><br>placebo.<br /><br>- To compare compliance with treatment with ONO-5334 or Alendronate versus<br /><br>placebo.<br /><br>- To compare the efficacy and safety of ONO-5334 versus Alendronate.<br /><br>- To investigate the efficacy and safety of three different doses of ONO-5334.</p><br>

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A multi-centre randomised double blind, placebo and active controlled parallel group study to investigate efficacy and safety of ONO-5334 in post menopausal women with osteopenia or osteoporosis.

Recruitment & Eligibility

Study & Design

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