A Randomized, Double-blind, Active-controlled Study to Evaluate the Efficacy and Safety of Denosumab Compared With Risedronate in Glucocorticoid-treated Individuals

Phase 3

Completed

• Conditions: Glucocorticoid induced osteoporosis; 10005959

• Registration Number: NL-OMON43823
• Lead Sponsor: Amgen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 14

Inclusion Criteria

4.1.1
- Glucocorticoid-initiating subpopulation: Men and women >= 18 years of age who have initiated Prednisone >= 7.5 mg daily or its equivalent within 3 months prior to screening and are expected to be treated with oral glucocorticoids for a total of at least 6 months, OR;
* Glucocorticoid-continuing subpopulation: Men and women >= 18 years of age who are taking Prednisone >= 7.5 mg daily or its equivalent for >= 3 months preceding screening and are expected to be treated with oral glucocorticoids for a total of at least 6 months.
4.1.2 Glucocorticoid-continuing subjects who are >= 50 years of age will be required to have a BMD value equivalent to a T-score <= -2.0 at the lumbar spine, total hip, or femoral neck; or a BMD value equivalent to a T-score <= -1.0 at the lumbar spine, total hip, or femoral neck and with a history of osteoporotic fracture.
4.1.3 Men and women < 50 years old at the time of screening in both glucocorticoid-continuing and glucocorticoid-initiating subpopulations, will be required to have a history of osteoporotic fracture.
4.1.4 Ambulatory;
4.1.5 At least two lumbar vertebrae from L1 through L4 and one hip must be evaluable by DXA (duplicate scans required);
4.1.6 Subject or subject*s legally acceptable representative has provided informed consent prior to any study specific procedures.

Exclusion Criteria

4.2.1 Received other OP treatment or bone active treatment with the following guidelines: a) Oral bisphosphonate use 1) > 3 months cumulatively in the past 2 years OR 2) > 1 month in the past year OR 3) Any use during the 3-month period prior to screening b) Administration of intravenous bisphosphonate, fluoride or strontium for OP within the last 5 years c) Parathyroid hormone (PTH) or PTH derivatives within the last year d) Denosumab for OP at any time in the past
4.2.2 Administration of any of the following treatment within 3 months of screening: Any selective estrogen receptor modulator (SERM) (estrogen agonist/ antagonist), Tibolone, Anabolic steroids or testosterone, Systemic hormone replacement therapy, Calcitonin, Other bone active drugs including anti-convulsants (except benzodiazepines) and heparin, Chronic systemic ketoconazole, androgens, adrenocorticotropic hormone (ACTH), cinacalcet, aluminum, lithium, protease inhibitors, gonadotropin-releasing hormone agonists
4.2.3 Administration of any of the following biologic agents within 4 weeks prior to screening: Anti alpha 4 integrin antibody (eg, natalizumab), Anti CD4/CD8 T-cells (eg, alefacept), Anti IL-12/IL-23 (eg, ustekinumab), CTLA4 inhibitor (eg, abatacept), IL1 receptor antagonist (eg, anakinra), IL6 inhibitor (eg, tocilizumab), Monoclonal antibody to CD20 (eg, rituximab), TNF antagonist (eg, adalimumab, certolizumab, golimumab, etanercept, infliximab)
4.2.4 Administering >1 biologic agent for the treatment of underlying inflammatory disease
4.2.5 Subject has an active infection or history of infections as follows: any active infection for which systemic anti-infectives were used within 4 weeks prior to screening, a serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to screening, recurrent or chronic infections or other active infection
4.2.6 Evidence of any of the following: History of hyperthyroidism (stable on antithyroid therapy is allowed), History of hypothyroidism (stable on thyroid replacement therapy is allowed), History of hypo- or hyperparathyroidism, History of Addison disease, History of osteomalacia, History of osteonecrosis of the jaw, History of recent tooth extraction or other dental surgery within the prior 6 months, Invasive dental work planned in the next 2 years, History of Paget*s disease of bone, Other bone diseases which affect bone metabolism
4.2.7 Abnormalities of the following per central laboratory reference ranges: Vitamin D deficiency, Hypercalcemia, Elevated transaminases, Elevated total bilirubin (TBL) as described in the protocol amendment 2 on page 30.

Study & Design

• Study Type: Interventional
• Study Design: Not specified