Study on Zoledronic Acid Use After Stopping Denosumab in Women with Postmenopausal Osteoporosis

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What is this study about?

This clinical trial is focused on studying postmenopausal osteoporosis, a condition where bones become weak and more likely to break after menopause. The study will use a treatment called zoledronic acid, which is given as a solution through an infusion. This treatment is being tested after patients stop using another medication called denosumab, which they have been taking for at least two years.

The purpose of the study is to compare two different ways of using zoledronic acid after stopping denosumab. One method is based on specific biological markers in the body, while the other follows a standard treatment plan. The study will last for one year, during which participants will receive the treatment and have their bone health monitored. Some participants may receive a placebo instead of the active treatment.

Throughout the study, the health of the participants’ bones will be checked using a special type of X-ray called dual-energy X-ray absorptiometry (DXA). This will help determine if the treatment is effective in maintaining bone density and preventing fractures. The study will also look at changes in certain markers in the blood that are related to bone health. Participants will be monitored for any side effects or adverse events during the study period.

1 joining the study

Upon joining the study, eligibility is confirmed. Participants are women aged 18 years or older with postmenopausal osteoporosis who have been treated with denosumab for at least two years.

Participants must have reached a decision to discontinue denosumab due to achieving therapeutic targets, such as no fractures during treatment, no new risk factors, and no significant decrease in bone density.

A signed consent form is required before any study-related procedures begin.

2 initial assessment

An initial assessment is conducted to establish baseline measurements. This includes a dual-energy x-ray absorptiometry (DXA) scan to measure bone mineral density (BMD) at the lumbar spine and hip.

Baseline levels of bone turnover markers are also recorded. These markers include substances like crosslaps, bone alkaline phosphatase, and osteocalcin.

3 treatment phase

Participants receive a treatment with zoledronic acid, administered as an infusion. The product used is ACIDE ZOLEDRONIQUE SANDOZ 5 mg/100 ml, solution for infusion.

The infusion is given once, and the response to treatment is monitored over the course of the study.

4 monitoring and follow-up

Participants are monitored for one year to assess the effectiveness of the treatment. This includes regular assessments of lumbar and hip BMD using DXA scans.

Changes in bone turnover markers are evaluated at the end of the first year and again at the end of the second year.

The occurrence of any new vertebral or peripheral fractures is recorded, along with any adverse events.

5 evaluation of outcomes

The primary outcome is the proportion of participants who maintain lumbar BMD after one year. A significant change is defined as a difference of more than 0.03 g/cm².

Secondary outcomes include the maintenance of hip BMD, changes in BMD from baseline, and the number of fractures and adverse events over the two-year period.

The need for a second infusion of zoledronic acid is also evaluated.

Who Can Join the Study?

Women who are 18 years or older.
Women with post-menopausal osteoporosis who have been treated with a medication called denosumab for at least 2 years.
Women with post-menopausal osteoporosis who have decided to stop using denosumab because they have reached their treatment goals. This means they have not had any fractures during treatment, have no new risk factors, and their bone mineral density (BMD) has not decreased by more than 0.03 g/cm² at the spine or hip.
Women with post-menopausal osteoporosis who have a history of a severe fracture or have a T-score of -2.5 or lower in the femur (thigh bone) or lumbar spine (lower back) before starting denosumab. A T-score is a measure used to assess bone density.
Participants must provide free, informed, and written consent signed by both the participant and the investigator. This must be done before any examination required by the research.
Participants must be affiliated with or beneficiaries of the French social security scheme.

Who Cannot Join the Study?

Patients who are not postmenopausal women cannot participate.
Patients who have not been previously treated with denosumab, a medication used to treat osteoporosis, are excluded.
Patients with any other bone diseases apart from osteoporosis are not eligible.
Patients with severe kidney problems cannot take part in the study.
Patients who are currently taking other medications that affect bone health are excluded.
Patients with a history of allergic reactions to the study medication, ZOL, are not allowed to participate.
Patients who are pregnant or breastfeeding cannot join the study.
Patients with any serious medical conditions that could interfere with the study are excluded.
Patients who are unable to follow the study procedures or attend follow-up visits are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Centre Hospitalier Universitaire De Lille	Lille	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Jean Rougier	Cahors	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Centre Hospitalier Le Mans	Le Mans	France
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Universitaire De Rennes	Rennes	France
Centre Hospitalier De Dax	Dax	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopital Beaujon	Clichy	France
Ctxttw Hwnrnjimjzt Ep Uupajjqocxiuq Dg Ldyeezs	Limoges	France
Asqimeupxa Pvnkbnvj Hdcsgqel Dm Mvfkvogus	Marseille	France
Iztkqryf dq Cmrarmmgndmm Huvqhuohkmn Umleicmuudche dz Siwoa Ewcwhwd (fmezaxy	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Zoledronic Acid Monohydrate

Zoledronic Acid is a medication used in this trial to help maintain bone density in patients with postmenopausal osteoporosis. It is administered after the withdrawal of another osteoporosis treatment, denosumab. The trial aims to compare two different strategies of using zoledronic acid: one based on specific biomarkers and another using a standardized approach. This medication works by slowing down the process of bone breakdown, which can help prevent fractures and maintain bone strength.

Denosumab is a medication that was used prior to the trial to treat postmenopausal osteoporosis. It works by inhibiting the cells responsible for bone resorption, thereby increasing bone mass and strength. In this trial, the focus is on what happens after stopping denosumab and how to best manage bone health with zoledronic acid.

Investigated diseases:

Osteoporosis postmenopausal

Postmenopausal Osteoporosis – This condition occurs in women after menopause, characterized by weakened bones and an increased risk of fractures. The decrease in estrogen levels during menopause leads to a reduction in bone density, making bones more fragile. Over time, this can result in fractures, particularly in the spine, hip, and wrist. The disease progresses as bone resorption outpaces bone formation, leading to a gradual loss of bone mass. Symptoms may not be apparent until a fracture occurs, often without significant trauma. Regular monitoring of bone density can help track the progression of the disease.

Trial ID:

2024-511871-13-00

Protocol code:

RC31/23/0370

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Zoledronic Acid Use After Stopping Denosumab in Women with Postmenopausal Osteoporosis

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