RGB-10 Phase 3 study

RGB-10 Phase 3 study -A comparative study to evaluate the similarity of RGB-10 to Forteo in patients with osteoporosis at high risk of fracture-

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223153

Enrollment

238

Registered

2016-03-28

Start date

2016-03-28

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoporosis

Interventions

investigational material(s) Generic name etc : RGB-10 INN of investigational material : Therapeutic category code : 243 Thyroid and para-thyroid hormone preparations Dosage and Administration for Inv

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with primary osteoporosis at high risk of fracture. 2. Female patients must be in the menopause for at least five years.

Exclusion criteria

Exclusion criteria: 1. Patients with secondary osteoporosis or patients suspected of having secondary osteoporosis. 2. Patients with low BMD (bone mineral density) diseases other than those with osteoporosis. 3. Patients judged by Investigators to have the conditions that affect the assessment of lumbar spine BMD by the DXA method. 4. Patients with new bone fracture within 12 weeks before the registration or during the screening period. 5. Patients with a history of, or concurrent malignant tumor. etc.

Design outcomes

Primary

Measure	Time frame
The percent change in lumbar spine (L2-L4) BMD BMD	—

Secondary

Measure	Time frame
Efficacy 1. The percent change in lumbar spine BMD (L1-L4). 2. The percent change in the femoral neck / the total hip BMD. 3. The percent change in the marker for bone formation. 4. The occurrence of fractures. Safety Adverse events BMD, marker for bone formation	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026