RECRUITING

Mechanisms of Anabolic Osteoporosis Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The aim of this study is to investigate the effect of romosozumab on bone cells during early and late phases of treatment.

Official Title

Mechanisms of Anabolic Osteoporosis Therapy

Quick Facts

Study Start:2023-06-14

Study Completion:2028-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05688969

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Female aged \> 45 years 2. Postmenopausal by either of the following criteria: 1. \> 36 since last spontaneous menses 2. \> 36 months since hysterectomy, plus serum FSH \> 40 units / liter if \< 60 years	* renal disease (stage 4 CKD) * elevated blood PTH (intact PTH \> 77 pg/ml). * serum 25-OH vitamin D \< 20 ng/ml * major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures. * excessive alcohol use or substance abuse that would preclude the subject from providing adequate informed consent or completing the protocol procedures. * known congenital or acquired bone disease other than osteoporosis. * exposure to oral bisphosphonates within the past 3 months, denosumab in the last 12 months, intravenous bisphosphonates within the past 24 months. * exposure to estrogens, SERMs, or calcitonin, oral or parenteral glucocorticoids for more than 14 days in the past 2 months. * any prior exposure to romosozumab.

Inclusion Criteria

Exclusion Criteria

1. Female aged \> 45 years
2. Postmenopausal by either of the following criteria:
1. \> 36 since last spontaneous menses
2. \> 36 months since hysterectomy, plus serum FSH \> 40 units / liter if \< 60 years

* renal disease (stage 4 CKD)
* elevated blood PTH (intact PTH \> 77 pg/ml).
* serum 25-OH vitamin D \< 20 ng/ml
* major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures.
* excessive alcohol use or substance abuse that would preclude the subject from providing adequate informed consent or completing the protocol procedures.
* known congenital or acquired bone disease other than osteoporosis.
* exposure to oral bisphosphonates within the past 3 months, denosumab in the last 12 months, intravenous bisphosphonates within the past 24 months.
* exposure to estrogens, SERMs, or calcitonin, oral or parenteral glucocorticoids for more than 14 days in the past 2 months.
* any prior exposure to romosozumab.

Contacts and Locations

Study Contact

Mackenzie Jordan

CONTACT

617-726-6129

MRJORDAN@mgh.harvard.edu

Principal Investigator

Benjamin Leder, MD

PRINCIPAL_INVESTIGATOR

Mass General Brigham

Study Locations (Sites)

Mass General Brigham

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Benjamin Leder, MD, PRINCIPAL_INVESTIGATOR, Mass General Brigham

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-14

Study Completion Date2028-12

Study Record Updates

Study Start Date2023-06-14

Study Completion Date2028-12

Terms related to this study

Additional Relevant MeSH Terms

Osteoporosis, Postmenopausal