Osteoporosis
Conditions
Interventions
MN-10-T or MN-10-T AI will be administered by subcutaneous injection.
Sponsors
Yoshitani Mai
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in lumbar spine bone mineral density (BMD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: -Incidence of clinical fractures. -Percent change from baseline in bone turnover markers. Safety: -Adverse events. -Vital signs. -Clinical laboratory tests. | — |
Contacts
Public ContactContact for Clinical Trial Information
ASAHI KASEI THERAPEUTICS CORPORATION
Outcome results
None listed