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Studies how bone cells respond during early and late phases of osteoporosis treatment

Studies bone cell changes during early and late treatment in postmenopausal women with osteoporosis.

Key facts

Who runs it
Massachusetts General Hospital
Where
Boston, United StatesSee the site
Trial code
Registry title
Mechanisms of Anabolic Osteoporosis Therapy
Status
Recruiting
People taking part
16 people, planned
Started
14 Jun 2023
Expected to end
Dec 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • early versus late biopsy
Record updated
18 December 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for postmenopausal women over 45 who have been prescribed romosozumab for osteoporosis and have not taken it before.

Age
Over 45 years
Sex
Women only
Disease stage
Postmenopausal osteoporosis at high risk of fracture (past osteoporotic fracture or multiple risk factors), or osteoporosis where other therapy failed or was not tolerated.
Earlier treatment
Must not have taken romosozumab before. Must not have recently used oral bisphosphonates (past 3 months), denosumab (past 12 months) or intravenous bisphosphonates (past 24 months).
Biomarker or test result
Postmenopausal: more than 36 since last spontaneous period, or more than 36 months since hysterectomy plus serum FSH above 40 units per liter if under 60 years.

Main reasons for not taking part

  • Kidney disease (stage 4 CKD)
  • High blood PTH (intact PTH above 77 pg/ml) or vitamin D (25-OH) below 20 ng/ml
  • Other known bone disease besides osteoporosis
  • Serious psychiatric illness, heavy alcohol use or substance abuse that would prevent consent or completing the study
  • Estrogens, SERMs, calcitonin or glucocorticoids for more than 14 days in the past 2 months

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • All postmenopausal women who are prescribed romosozumab by their treating physicians, meet the FDA-defined indication for romosozumab, and who are not at increased risk for a bone marrow aspirate or bone biopsy will be offered enrollment. The FDA approved indication for romosozumab is: "the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy." Volunteers must be:
  • Female aged > 45 years
  • Postmenopausal by either of the following criteria:; > 36 since last spontaneous menses; > 36 months since hysterectomy, plus serum FSH > 40 units / liter if < 60 years

Who cannot take part

  • any prior exposure to romosozumab
  • renal disease (stage 4 CKD)
  • major psychiatric disease that in the opinion of the investigator would preclude the subject from providing adequate informed consent or completing the protocol procedures
  • known congenital or acquired bone disease other than osteoporosis
  • serum 25-OH vitamin D < 20 ng/ml
  • elevated blood PTH (intact PTH > 77 pg/ml)
  • excessive alcohol use or substance abuse that would preclude the subject from providing adequate informed consent or completing the protocol procedures
  • 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

Where in United States

  • Mass General BrighamBoston, United StatesContact: Mackenzie JordanTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Early BiopsyExisting treatment, for comparison

    The investigators will perform paired iliac crest bone biopsies in postmenopausal women who meet standard romosozumab treatment indications and are being prescribed romosozumab by their treating physician. All study volunteers will have a bone biopsy procedure prior to starting therapy, and then an identical procedure at the contralateral side either 3-6 weeks ("early") or 6-8 months ("late") after starting therapy. This is not a clinical trial: the investigators will not be assigning volunteers to a specific osteoporosis therapy, though the investigators will randomize volunteers to either the early or late second biopsy.

    Treatment: early versus late biopsy

  • Late BiopsyExisting treatment, for comparison

    The investigators will perform paired iliac crest bone biopsies in postmenopausal women who meet standard romosozumab treatment indications and are being prescribed romosozumab by their treating physician. All study volunteers will have a bone biopsy procedure prior to starting therapy, and then an identical procedure at the contralateral side either 3-6 weeks ("early") or 6-8 months ("late") after starting therapy. This is not a clinical trial: the investigators will not be assigning volunteers to a specific osteoporosis therapy, though the investigators will randomize volunteers to either the early or late second biopsy.

    Treatment: early versus late biopsy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Mechanisms of Anabolic Osteoporosis Therapy
Plain-language title
Studies how bone cells respond during early and late phases of osteoporosis treatmentGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
18 December 2025