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A Phase III Study of MN-10-T in Patients with Osteoporosis at High Risk of Fracture

A Phase III Study of MN-10-T in Patients with Osteoporosis at High Risk of Fracture

Yoshitani Mai

ASAHI KASEI THERAPEUTICS CORPORATION

1-1-2 Yurakucho, Chiyoda-ku, Tokyo

ct-info@om.asahi-kasei.co.jp

Contact for Clinical Trial Information

ASAHI KASEI THERAPEUTICS CORPORATION

1-1-2 Yurakucho, Chiyoda-ku, Tokyo

+81-3-6699-3600

ct-info@om.asahi-kasei.co.jp

Recruiting

April. 14, 2026

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

Patients with osteoporosis at high risk of fracture despite having received a cumulative duration of teriparatide treatment of 24 months.
Patients who are considered by the investigators to have a high need for retreatment with or continued treatment of a teriparatide treatment
Japanese male or female patients aged 65 years or older at the time of obtaining informed consent.
Ambulatory outpatients who are able to walk independently.
Patients who are able to sufficiently understand the content of the clinical trial and have the capacity to provide informed consent.

Patients with any of the following diseases associated with low bone mass other than osteoporosis:
Multiple myeloma, Vertebral hemangioma, Spinal tuberculosis, Pyogenic spondylitis, Others
Patients with any of the following treatment histories:
- Patients who have previously received abaloparatide.
- Patients who have received an anti-RANKL antibody product or an anti-sclerostin antibody product, including those administered in clinical trials, within 12 months prior to the start of investigational product administration.
Patients who are otherwise considered by the investigators to be unsuitable for participation in this clinical trial (patients with dementia must be excluded at a minimum).

Both

Osteoporosis

MN-10-T or MN-10-T AI will be administered by subcutaneous injection.

Percent change from baseline in lumbar spine bone mineral density (BMD)

Efficacy:
- Incidence of clinical fractures.
- Percent change from baseline in bone turnover markers.
Safety:
- Adverse events.
- Vital signs.
- Clinical laboratory tests.

+81-3-5213-0028

Mar. 27, 2026

Yes

Individual participant-level data will be made available in a secure access environment, subject to review and approval by an independent review committee. All data shared with external researchers will be anonymized to protect participant privacy.

none