Fracture prevention using selective estrogen receptor modulator in patients with osteoporosis who received radiation therapy for cervical cancer

JRCT ID: jRCT1061220067

Registered date:04/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cervical cancer
• Date of first enrollment: 24/10/2022
• Target sample size: 80
• Study type: Interventional

Intervention(s)

DEXA will be performed before and after radiotherapy and during the follow-up period to check for osteoporosis.
The osteoporosis group will receive osteoporosis drugs including selective estrogen receptor modulator,SERM and exercise therapy. Non-osteoporotic patients are instructed to exercise.

Outcome(s)

Primary Outcome

New pelvic fractures within the irradiation field 2 years after completion of radiotherapy
*Fractures within the irradiation field are defined as fractures of the ilium, pubis, sit bones, sacrum, and fifth lumbar vertebrae.

Secondary Outcome

(1) New fragility fractures of the whole body 2 years after completion of radiotherapy
(2) Changes in pain scale
(3) Changes in bone density, bone resorption markers, and bone matrix-related markers
(4) Progression-free survival
(5) Overall survival

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Female

Include criteria

Patients who meet all of the following criteria will be considered.
Patients with histologically confirmed cervical cancer.
Patients who are scheduled to receive radical radiotherapy, including concomitant intracavitary irradiation, as initial treatment for cervical cancer.
Postmenopausal patients ,menstrual amenorrhea for at least twelve months prior to the start of radiotherapy.
Patients who have given written consent to participate in the study.

• Exclude criteria: Patients who are expected to have difficulty completing the study or subsequent follow-up, or who are deemed unsuitable by their physicians.

Related Information

• Primary Sponsor: Nagao Shoji