Prospective, randomized, multicentre study to compare the efficacy at 52 weeks (1 year) of biosimilar teriparatide and alendronate in the prevention of new morphometric vertebral fractures and/or worsening of previous vertebral fractures in women with a clinical vertebral fracture or recent hip fracture (imminent risk of fracture) caused by bone fragility.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Gedeon Richter Iberica S.A.

Participant type

Patients

Age range

65+ years

Gender

Female

Therapeutic area

Diseases [C] - Musculoskeletal Diseases [C05]

Decision date (initial)

2025-02-26

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-521301-40-00

EudraCT number

2020-005712-22

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To evaluate the efficacy of biosimilar teriparatide compared to alendronate in reducing the incidence of new morphometric vertebral fractures and/or worsening of previous fractures in women over 65 years of age with recent clinical vertebral fracture or hip fracture caused by bone fragility after 52 weeks of treatment.

Secondary objectives 1

1. To evaluate the differences between patients treated with biosimilar teriparatide and those treated with alendronate in: Incidence of new morphometric vertebral fractures and/or worsening of previous fractures at 26 weeks of treatment. Incidence of new clinical vertebral fractures at 26 and 52 weeks. Incidence of moderate and severe vertebral fractures (grades 2 and 3) at 26 and 52 weeks. Incidence of multiple vertebral fractures at 26 and 52 weeks. Incidence of non-vertebral fractures at 26 and 52 weeks. Incidence of major non-vertebral fractures (proximal humerus, distal radius and proximal femur) at 26 and 52 weeks. Changes in BMD (Bone Mineral Density) at 52 weeks. Changes in TBS (Trabecular Bone Score) at 52 weeks. Reduction in spinal pain, using a visual analogue scale (VAS) at 10, 26 and 52 weeks. Improvement in quality of life, using the EQ-5D questionnaire at 26 and 52 weeks. Evaluation of patient adherence to teriparatide and alendronate by the delivery of their used cartridges or ampoules respectively, at visits 2, 3 and 4 (approximately 10, 26 and 52 weeks). Safety (adverse events).

Conditions and MedDRA coding

Prevention of new morphometric vertebral fractures and/or worsening of previous vertebral fractures.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

1. 1. Women aged > 65 years. 2. Recent (< 3 months) clinical vertebral fragility fracture confirmed by X-ray or recent (< 3 months) hip fragility fracture (femoral neck or trochanteric). 3. Patients who authorize their participation in the study by signing the written informed consent.

Exclusion criteria 1

1. 1. Hypercalcaemia. 2. Severe vitamin D deficiency (25-hydroxyvitamin D < 10 ng/ml). If the serum concentration of 25-hydroxyvitamin D is 10-30 ng/ml, the patient may be included, but rapid supplementation with cholecalciferol or calcifediol will be carried out according to standard clinical practice. 3. Primary hyperparathyroidism. 4. Paget's disease of bone. 5. Contraindication to any of the treatments in the study. 6. Unexplained parathyroid hormone (PTH) elevation or alkaline phosphatase (ALP). 7. Previous use of intravenous zoledronate in the 52 weeks before inclusion in the study, intravenous ibandronate or pamidronate in the 3 months before inclusion in the study, denosumab in the 52 weeks before inclusion in the study, or prior use of the parathyroid hormone, teriparatide, another analog hormone or sodium fluoride at therapeutic doses at any time. Previous treatment with other antiosteoporotic drugs is permitted, provided that they are not being taken at the time of inclusion in the study. 8. Having received at least 1 dose of romosozumab at any previous time. 9. Patients who, for any reason (cognitive, socio-economic, etc.), have particular difficulties adhering to treatment 10. Having suffered two or more previous vertebral fractures* 11. Patients who, due to their characteristics and according to the doctor's criteria, could benefit more from treatment for osteoporosis other than those in the study, such as denosumab or zoledronic acid** * in these patients, it might be more justified to treat with teriparatide rather than with bisphosphonates ** denosumab might be preferable in patients with renal insufficiency, documented intolerance or contraindication to oral bisphosphonates, polypharmacy or who prefer subcutaneous administration every 6 months to daily treatment; zoledronic acid may be preferable in patients with documented intolerance or contraindication to oral bisphosphonates, polypharmacy, and bedridden patients or those with severe functional impairment.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. The main evaluation criterion will be the percentage of patients with at least one new morphometric vertebral fracture (incident vertebral fractures) or the increase in severity of a known vertebral fracture (vertebral re-fracture) during the 52-week study period. For the diagnosis and grading of vertebral fractures, the Genant semi-quantitative method will be used on thoracic and lumbar radiographs.

Secondary endpoints 1

1. new morphometric vertebral fractures or increased severity of a known vertebral fracture new clinical vertebral fractures; new non-vertebral fractures and new major non-vertebral fractures; change in BMD with respect to baseline; with respect to baseline; vertebral pain through the VAS-pain with respect to baseline & evaluation of therapeutic adherence; quality of life using the EQ-5D questionnaire with respect to baseline; frequency of AEs, SAEs, and AEs leading to treatment discontinuation

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Comparator 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Gedeon Richter Iberica S.A.

Sponsor organisation

Gedeon Richter Iberica S.A.

Address

Calle De Pedro I Pons 9-11 Planta 7

City

Barcelona

Postcode

08034

Country

Spain

Scientific contact point

Organisation

Gedeon Richter Iberica S.A.

Contact name

Elisabet Augé Marí

Public contact point

Organisation

Gedeon Richter Iberica S.A.

Contact name

Elisabet Augé Marí

Locations

1 EU/EEA country · 20 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 5 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

4 submissions — initial application plus substantial / non-substantial modifications