TWICE-Follow up study

TWICE-Follow up study - TWICE-Follow up study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046026

Enrollment

Registered

2021-11-15

Start date

2021-11-07

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

primary osteoporosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who participate in the clinical trial (JapcCTI-16377) between January 2017 and July 2017, and received teriparatide agents for 48 weeks. (2) Patients who could be followed for another 24 months after the above clinical trial was completed.

Exclusion criteria

Exclusion criteria: (1) Patients who have been denied data use by opt-out (2) Patients who are judged to be inappropriate by the investigator or researcher

Design outcomes

Primary

Measure	Time frame
Difference in rate of change in lumbar spine bone mineral density from the start of early-stage treatment to 24 months later of late-stage treatment (grouped by treatment method)	—

Secondary

Measure	Time frame
(1) Group by early-stage treatment and late-stage treatment, and calculate summary statistics within groups (a) and (b) for each of the following indicators (A), (B), and (C). In addition, anterior-posterior comparison within the group and a comparison between the groups are performed. (2) Calculate summary statistics for each of the following indicators (D) and (E) from before the start of pretreatment to 24 months after the start of posttreatment. In addition, comparison between groups is performed. (A) Bone mineral density (lumbar spine, proximal femur total, femoral neck) (B) Bone turnover markers (TRACP-5b, P1NP, u-NTX, OC, CTX) (C) Femoral cortical bone analysis by 3D-shaper (D) New fracture (E) Adverse events for which a causal relationship cannot be denied (a) The amount of change and rate of change of followings: starting from before the start of early-stage treatment to the end of early-stage treatment; starting from before the start of early-stage treatment to 12 months after the start of late-stage treatment; starting from before the start of early-stage treatment to 24 months after the start of late-stage treatment. (b) The amount of change and rate of change of followings: starting from the start of late-stage treatment to 12 months after the start of late-stage treatment and 24 months after the start of late-stage treatment.	—

Measure

Time frame

(1) Group by early-stage treatment and late-stage treatment, and calculate summary statistics within groups (a) and (b) for each of the following indicators (A), (B), and (C). In addition, anterior-posterior comparison within the group and a comparison between the groups are performed. (2) Calculate summary statistics for each of the following indicators (D) and (E) from before the start of pretreatment to 24 months after the start of posttreatment. In addition, comparison between groups is performed. (A) Bone mineral density (lumbar spine, proximal femur total, femoral neck) (B) Bone turnover markers (TRACP-5b, P1NP, u-NTX, OC, CTX) (C) Femoral cortical bone analysis by 3D-shaper (D) New fracture (E) Adverse events for which a causal relationship cannot be denied (a) The amount of change and rate of change of followings: starting from before the start of early-stage treatment to the end of early-stage treatment; starting from before the start of early-stage treatment to 12 months after the start of late-stage treatment; starting from before the start of early-stage treatment to 24 months after the start of late-stage treatment. (b) The amount of change and rate of change of followings: starting from the start of late-stage treatment to 12 months after the start of late-stage treatment and 24 months after the start of late-stage treatment.

—

Countries

Japan

Contacts

Public ContactMori

Shido. Inc. N/A

info@shido.co.jp03-4500-5075

Outcome results