Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:55 AM
Ignite Modification Date:
2025-12-25 @ 4:55 AM
NCT ID:
NCT03457818
Eligibility Criteria:
Inclusion Criteria:
1. An understanding, ability and willingness to fully comply with study procedures and restrictions.
2. Ability to voluntarily provide written, signed and dated informed consent as applicable to participate in the study.
3. Postmenopausal women age ≥ 50 and ≤ 90 years at time of consent.
4. Diagnosis of T2D for ≥ 2 years. Upon review of patient's medical history, patient will be confirmed to currently have reasonably controlled T2D as assessed by the investigator, with HbA1c ≤ 8.4%. If HbA1c is ≥ 8.5%, re-screening will be allowed after approximately 3 months following adjustment of diabetes therapy.
5. DXA T-score ≤ -1.0 at one or more sites (lumbar spine, femoral neck, total hip or distal 1/3 radius).
6. Normal albumin-adjusted serum calcium level.
Exclusion Criteria:
1. Hormone replacement treatment use (to avoid the influence of estrogen).
2. Fractures (excluding skull, facial bones, metacarpals, fingers, toes, and fractures associated with severe trauma) within 12 months.
3. A history of pathological fractures (eg, due to Paget's disease, myeloma, metastatic malignancy).
4. Type 1 diabetes.
5. Disorders associated with altered skeletal structure or function (chronic renal disease stage 4 or worse, chronic liver disease, malignancy, hypoparathyroidism or hyperparathyroidism, acromegaly, Cushing's syndrome, hypopituitarism, chronic obstructive pulmonary disease, alcohol intake \> 3 units/day).
6. Treatment with any of the following drugs in past year: anticonvulsant therapy, pharmacological doses of thyroid hormone (TSH\<normal is permitted if subject has normal T4, clinical euthyroidism and is in steady-state), adrenal or anabolic steroids, calcitonin, estrogen or selective estrogen receptor modulator, sodium fluoride (other than dental treatment), teriparatide, denosumab, abaloparatide, strontium or aromatase inhibitors; any history of bisphosphonate treatment. Corticosteroid use permitted if subject is in steady-state.
7. Serum 25(OH)D levels \< 20 ng/ml. If 25(OH)D levels are \< 20 ng/ml, rescreening will be allowed following a vitamin D loading regimen of 50,000 IU/week for 4 weeks. If serum 25(OH)D levels are ≥ 20 ng/ml after supplementation, the subject will be allowed to enroll.
8. Clinically significant hypersensitivity to denosumab or any components of denosumab 60 mg.
9. Known sensitivity to any of the products to be administered during the study (e.g., calcium or vitamin D).
10. Subject is pregnant or breast feeding, or planning to become pregnant within 5 months after the end of treatment.
11. Female subject of child bearing potential and is not willing to use, in combination with her partner, highly effective contraception during treatment and for 5 months after the end of treatment.
12. Significant dental/oral disease, including prior history or current evidence of osteonecrosis/osteomyelitis of the jaw, or the following:
* Active dental or jaw condition which requires oral surgery
* Non-healed dental/oral surgery
* Planned invasive dental procedures for the course of the study
13. DXA T-score of ≤ -3.5 at any site.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
50 Years
Maximum Age:
90 Years
Study:
NCT03457818
Study Brief:
Protocol Section:
NCT03457818