A Multi-Center Retrospective Study to Describe Clinical Characteristics and Outcomes of Early EVENITY Users, Transitioning to Antiresorptive Agents in Japan

A Multi-Center Retrospective Study to Describe Clinical Characteristics and Outcomes of Early EVENITY Users, Transitioning to Antiresorptive Agents in Japan - A Multi-Center Retrospective Study to Describe Clinical Characteristics and Outcomes of Early EVENITY Users, Transitioning to Antiresorptive Agents in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000042554

Enrollment

1000

Registered

2020-11-26

Start date

2020-11-27

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

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with OP at high risk of fracture, defined by the Japanese Society for Bone and Mineral Research and Japan Osteoporosis Society as below (at least one of the following must be met): - Any of LS, TH, or FN BMD below -2.5 standard deviation (SD) and history of at least one fragility fracture - LS BMD less than -3.3 SD - Presence of 2 or more prevalent vertebral Fxs - Any prevalent vertebral Fxs with semi-quantitative (SQ) grade 3 - Other risk factors (cf. prevalent hip fracture) 2. Patients starting treatment with EVENITY after 4th March 2019 and completing 12 months of treatment and having first sequential therapy data for 6 months or longer.

Exclusion criteria

Exclusion criteria: Conditions specified as contraindication in Japanese package insert: - Patients with a history of hypersensitivity to any of the ingredients of EVENITY - Patients with hypocalcemia

Design outcomes

Primary

Measure	Time frame
- Baseline demographics (age, sex, years since menopause, weight, height) at the initiation of EVENITY - Recent BMD T-score - Prevalent Fxs (including timing of most recent) - Family history of hip Fxs - Rheumatoid Arthritis (RA) prevalence - Co-administered medications (eg, active vitamin D3) - Most recent previous OP medications (active vitamin D3, selective estrogen receptor modulators [SERMs], bisphosphonates [BISs], denosumab, teriparatide [TPTD]) - History of cardiovascular disease, and other comorbidities - Healthcare utilization preceding initiation of EVENITY - Substance use (smoking status and alcohol consumption at EVENITY initiation) - 10-year probability of major osteoporotic and hip FXs based on WHO risk factor criteria (FRAX) calculated with actual femoral neck BMD (in g/cm2) or T-score	—

Measure

Time frame

- Baseline demographics (age, sex, years since menopause, weight, height) at the initiation of EVENITY - Recent BMD T-score - Prevalent Fxs (including timing of most recent) - Family history of hip Fxs - Rheumatoid Arthritis (RA) prevalence - Co-administered medications (eg, active vitamin D3) - Most recent previous OP medications (active vitamin D3, selective estrogen receptor modulators [SERMs], bisphosphonates [BISs], denosumab, teriparatide [TPTD]) - History of cardiovascular disease, and other comorbidities - Healthcare utilization preceding initiation of EVENITY - Substance use (smoking status and alcohol consumption at EVENITY initiation) - 10-year probability of major osteoporotic and hip FXs based on WHO risk factor criteria (FRAX) calculated with actual femoral neck BMD (in g/cm2) or T-score

—

Secondary

Measure	Time frame
- Absolute value and percent change from baseline at each available time points for BTMs (Type I procollagen-N-propeptide [P1NP], bone specific alkaline phosphatase [BAP], Type I collagen cross-linked C-telopeptide [CTX], tartrate-resistant acid phosphatase 5b [TRACP-5b], Type I collagen cross-linked N-telopeptide [NTX]) and BMD (lumbar spine [LS], total hip [TH], femoral neck [FN]) at 12 months (completion of EVENITY therapy) from baseline - Absolute value and percent change in BMD and BTMs at 18 months (at least 6 months of first sequential therapy post EVENITY therapy) from baseline - Adherence/compliance during EVENITY therapy - Types of first sequential therapy following EVENITY therapy and the reasons for the choice of the sequential therapy	—

Measure

Time frame

- Absolute value and percent change from baseline at each available time points for BTMs (Type I procollagen-N-propeptide [P1NP], bone specific alkaline phosphatase [BAP], Type I collagen cross-linked C-telopeptide [CTX], tartrate-resistant acid phosphatase 5b [TRACP-5b], Type I collagen cross-linked N-telopeptide [NTX]) and BMD (lumbar spine [LS], total hip [TH], femoral neck [FN]) at 12 months (completion of EVENITY therapy) from baseline - Absolute value and percent change in BMD and BTMs at 18 months (at least 6 months of first sequential therapy post EVENITY therapy) from baseline - Adherence/compliance during EVENITY therapy - Types of first sequential therapy following EVENITY therapy and the reasons for the choice of the sequential therapy

—

Countries

Japan

Contacts

Public ContactTakashi Takahashi

IQVIA Services Japan K.K. Real-World Evidence Services

takashi.takahashi@iqvia.com03-6859-9500

Outcome results