Comparative Persistence With Prolia and Weekly Alendronate in 5 Asia-Pacific countries: a Prospective Observational Study.

Comparative Persistence With Biannual Prolia and Weekly Alendronate in post-menopausal women with osteoporosis living in one of 5 Asia-Pacific countries: a Prospective Observational Study.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12621001208897

Enrollment

446

Registered

2021-09-09

Start date

2020-02-10

Completion date

2021-09-09

Last updated

2021-09-13

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

Conditions

None listed

Brief summary

The primary objective of this study is to compare persistence with Prolia to persistence with weekly alendronate in postmenopausal women with osteoporosis at 12 months. The clinical hypothesis is that denosumab 60 mg 6-monthly subcutaneous (Prolia) treatment will result in a higher proportion of patients being persistent at 12 months of treatment compared with 70 mg once weekly alendronate treatment in the 5 Asian-Pacific countries included in this study.

Interventions

Patients are postmenopausal women receiving treatment for osteoporosis in accordance with the approved local Prescribing Information in 5 Asia-Pacific countries where Prolia and alendronate are commercially available (Australia, Taiwan, Korea, Hong Kong, Singapore, and Thailand). Patients will be enrolled in 1 of 2 treatment groups based on their current prescription: • Prolia 60 mg 6 monthly subcutaneous injections • alendronate 70 mg once weekly orally (branded, branded combination therapy, or generic) Enrollment period is expected to take approximately 24 months. Each patient will be followed for approximately 24 months from the time of enrollment to the end of study. The total duration of the study is expected to be about 4 years.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Postmenopausal women eligible for treatment for osteoporosis in accordance with the approved local Prescribing Information

Exclusion criteria

Patient has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the patient to give written informed consent. Patient has contraindication for treatment with Prolia and alendronate according to the approved local Prescribing Information.

Outcome results