Osteoporosis Trial, Recruiting NCT05202678 Sponsor: AgNovos Healthcare, LLC Condition: Osteoporosis
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Osteoporosis Trial, Recruiting

NCT05202678
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are a woman who has gone through menopause and has not had a period for at least one year
  • Your hip bone scan (DXA) shows a T-score of -2.5 or lower, meaning you have significant bone loss from osteoporosis in your hip
  • At least one of your hips has never had surgery or a fracture
  • You are in generally stable health, with no serious ongoing health concerns from past treatments or procedures (confirm with trial site)
  • You are willing, able, and committed to attending all check-up appointments for the full length of the study
  • You are able to read, understand, and sign a consent form to join the study

Who may not be able to join:

  • You have had hip fracture repair, a hip replacement, or hip joint surgery within the last 3 months
  • You have had increasing hip pain over the last 6 months that may suggest a serious joint or tissue problem, such as arthritis, a torn hip cartilage, a stress fracture, a tumour, or infection (confirm with trial site)
  • You use a wheelchair full-time or are unable to get out of bed
  • Your blood calcium levels are outside the normal range, or you have a condition that affects how your body processes calcium (such as hypercalcemia)
  • You have severely reduced kidney function or are currently on dialysis
  • Your blood sugar control is poor, shown by a specific blood test result (HbA1c) of 7.5% or higher
  • Your Body Mass Index (BMI) is over 35
  • You smoke heavily or use a lot of smokeless tobacco, as judged by the study doctor (confirm with trial site)
  • You have serious health conditions that place you in a higher-risk medical category (confirm with trial site)
  • You drink alcohol excessively, as judged by the study doctor (confirm with trial site)
  • Your hip X-rays show significant bone or joint problems, including signs of a specific type of unusual thigh bone fracture
  • You have taken steroid medications (such as cortisone or prednisone) for 10 or more days in the past 6 months
  • You have taken immune-suppressing medications at any point in the past 12 months
  • You have a bone disease other than osteoporosis, such as Paget's disease
  • You have a history of an autoimmune joint condition, such as rheumatoid arthritis, psoriatic arthritis, lupus, or Crohn's disease
  • You have had radiation therapy to your hip or pelvic area in the past
  • You have a history of cancer (other than a common minor skin cancer called basal cell carcinoma), unless you have been fully treated and have had no signs of cancer for at least 5 years
  • You have a known allergy to the type of implanted device used in this trial
  • The study doctor does not feel you are a suitable candidate for other reasons, such as difficulty attending appointments, other health concerns, or substance use issues
  • You are currently participating in another clinical trial

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Jo De Schepper, MD, AZ Nikolaas

Phone: +1 240 753 6500

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
AgNovos Healthcare, LLC
Registry
ClinicalTrials.gov
Start date
5 July 2021
Est. completion
1 December 2025

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

Femoral Neck Bone Mineral Density; Primary Safety Evaluation

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov