Controlled Study of ONO-5334 in Postmenopausal Women With Osteopenia or Osteoporosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the efficacy and safety of ONO-5334 in postmenopausal women with osteopenia or osteoporosis.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Investigational Drug in Osteoporosis (MK-0217-908)

NCT00092053

Postmenopausal Osteoporosis

COMPLETED PHASE3

Effects of Teriparatide or Denosumab on Bone in Postmenopausal Women With Osteoporosis

NCT01753856

Osteoporosis

COMPLETED PHASE4

A Study to Determine the Satisfaction With Actonel in Postmenopausal Women With Osteoporosis

NCT00632216

Osteoporosis, Postmenopausal

COMPLETED PHASE4

Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

NCT00212628

Involutional Osteoporosis

COMPLETED PHASE3

Controlled Study of ONO-5920 in Patients With Involutional Osteoporosis in Japan

NCT00212719

Involutional Osteoporosis

COMPLETED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoporosis Osteopenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

P

Group Type PLACEBO_COMPARATOR

ONO-5334

Intervention Type DRUG

Placebo - 24/mos.

E1

Group Type EXPERIMENTAL

ONO-5334

Intervention Type DRUG

100mg QD /24 months

E2

Group Type EXPERIMENTAL

ONO-5334

Intervention Type DRUG

50mg BID /24 mos.

E3

Group Type EXPERIMENTAL

ONO-5334

Intervention Type DRUG

300mg QD /24 mos.

A

Group Type ACTIVE_COMPARATOR

ONO-5334

Intervention Type DRUG

Alendronate 70mg once weekly / 24 mos

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ONO-5334

Placebo - 24/mos.

Intervention Type DRUG

ONO-5334

100mg QD /24 months

Intervention Type DRUG

ONO-5334

50mg BID /24 mos.

Intervention Type DRUG

ONO-5334

300mg QD /24 mos.

Intervention Type DRUG

ONO-5334

Alendronate 70mg once weekly / 24 mos

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1\. Osteoporosis defined as a value DXA BMD 2.5 SD or more below the young adult mean (T-score, ≤-2.5) at the lumbar spine (L1 to L4) or total hip, OR

* Osteoporosis defined as a value of DXA BMD more than 1 SD below the young adult mean, but less than 2.5 SD below this value (T-score \<-1 and \>2.5) at the lumbar spine (L1 to L4) or total hip.

Exclusion Criteria

1. Patients with a value of DXA BMD more that 3.5 SD below the young adult mean, (T-score \<-3.5) at the lumbar spine (L1 to L4) or total hip.
2. Osteoporosis patients (T-score ≤-2.5) who have any vertebral fragility fracture between T4 and L4 inclusive.
3. Osteopenia patients (T-score \<-1 and \>-2.5) who have no vertebral fragility fractures between T4 and L4 inclusive, OR

* Osteopenia patients (T-score \<-1 and \>-2.5) who have two or more vertebral fragility fractures between T4 and L4 inclusive.
4. Patients who have abnormalities of the lumbar spine or femoral neck or internal organs around them precluding the assessment of BMD.
5. Patients who have secondary causes of osteoporosis or other disorders of bone and mineral metabolism.

Minimum Eligible Age

55 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No