Clinical trial NCT06164795: Sequential Therapies After Osteoanabolic Treatment
Official title: Efficacy of Sequential Therapies After Osteoanabolic Treatment in Postmenopausal Women With Severe Osteoporosis: the Sequential Treatment After Romosozumab and Teriparatide/Abaloparatide (START) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoporosis, Postmenopausal
Lead sponsor: 424 General Military Hospital
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 150
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Postmenopausal women treated with severe osteoporosis

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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: lumbar spine bone mineral density
timeFrame: baseline to 12 months
Secondary outcomes:
measure: femoral neck bone mineral density
timeFrame: baseline to 12 months
measure: total hip bone mineral density
timeFrame: baseline to 12 months
measure: P1NP
timeFrame: baseline, 3 months, 6 months, 12 months
measure: CTx
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Fractures
timeFrame: 12 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: 251 Airforce & VA General Hospital
city: Athens
country: Greece
facility: First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens
city: Athens
country: Greece
facility: , KAT General Hospital
city: Thessaloniki
country: Greece
facility: 424 General Military Hospital
city: Milan
country: Italy
facility: Fondazione IRCCS Cà Granda-Ospedale Maggiore Policlinico
city: Roma
country: Italy
facility: Campus Bio-Medico University
city: Siena
country: Italy
facility: Department of Medicine, Surgery and Neurosciences, University of Siena
city: Udine
country: Italy
facility: University-Hospital S. Maria della Misericordia
Study officials:
affiliation: ECTS Clinical Action Group
name: Willem Lems, Prof
role: STUDY_CHAIR
References: