Sequential Therapies After Osteoanabolic Treatment (START)

424 General Military Hospital

Status: Enrolling

Conditions: Osteoporosis, Postmenopausal

Treatments: Drug: Denosumab; Drug: Teriparatide; Drug: Zoledronate; Drug: Romosozumab; Drug: Abaloparatide Injection (80 mcg)

Study type: Observational

Funder types: Other

Identifiers

NCT06164795

START

Details and patient eligibility

About

12-month prospective, open-label, multicenter, international, observational study evaluating sequential treatments after osteoanabolics

Full description

Caucasian women with severe postmenopausal osteoporosis who have completed their course with romosozumab or a PTH analog will be assigned to one of the following 3 options: i) zoledronate 5mg infusion or ii) denosumab subcutaneous injections or iii) teriparatide or abaloparatide (for those previously treated with romosozumab) or romosozumab (for those previously treated with teriparatide or abaloparatide).

Endpoints: Primary: BMD changes at the lumbar spine at 12 months. Secondary: i) BMD changes at the non-dominant femoral neck and total hip at 12 and 24 months; ii) changes at levels of bone turnover markers throughout the study; iii) incident fractures: vertebral (clinical and morphometric identified on VFA scans) and non-vertebral

Enrollment: 150 estimated patients

Sex: Female

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women treated with severe osteoporosis completing their course with romosozumab or teriparatide

Exclusion criteria

• a bone disease other than postmenopausal osteoporosis
• use of medications other than romosozumab or teriparatide affecting bone metabolism during the last 12 months before entering the study
• creatinine clearance <60 mL/min/1.73 m2
• liver failure
• any type of cancer
• uncontrolled endocrine diseases
• serum 25-hydroxy vitamin D (25-OHD) concentrations lower than 20 ng/mL (50 nmol/L)
• hypersensitivity to denosumab or zoledronate or teriparatide or romosozumab or any of the excipients

Trial design

150 participants in 6 patient groups

Romo-Zol group

Description:

Postmenopausal women treated with romosozumab for 12 months will receive a single zoledronate infusion (5mg) at 1 month after the last romosozumab dose

Treatment:

Drug: Zoledronate

Romo-Dmab group

Description:

Postmenopausal women treated with romosozumab for 12 months will receive subcutaneous denosumab injections (60mg) bi-annually for 12 months starting at 1 month after the last romosozumab dose

Treatment:

Drug: Denosumab

Romo-PTH group

Description:

Postmenopausal women treated with romosozumab for 12 months will receive daily injections of teriparatide 20μg or abaloparatide 80μg for 12 months starting at 1 month after the last romosozumab dose

Treatment:

Drug: Abaloparatide Injection (80 mcg)

Drug: Teriparatide

PTH-Zol group

Description:

Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 monthswill receive a single zoledronate infusion (5mg) at 1 month after the last romosozumab dose

Treatment:

Drug: Zoledronate

PTH-Dmab group

Description:

Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive subcutaneous denosumab injections (60mg) bi-annually for 12 months

Treatment:

Drug: Denosumab

TPTD-Romo group

Description:

Postmenopausal women treated with teriparatide for 24 months or abaloparatide for 18 months will receive month injections of romosozumab for 12 months

Treatment:

Drug: Romosozumab