Denosumab Adherence Preference Satisfaction Study

NCT00518531 | Completed Phase 3 Results

• 2 other identifiers: 20060232DAPS
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary objective is to evaluate the adherence of subjects to subcutaneous (SC) 60 mg denosumab every 6 months (Q6M) treatment compared to oral 70 mg alendronate once a week (QW) treatment at the end of treatment period 1 (12 months).

Conditions

Osteoporosis

Keywords

osteoporosis; low bone mineral density; alendronate; denosumab; adherence; preference; satisfaction; postmenopausal; women

Outcome Measures

Primary Outcomes (1)

• Adherence With Treatment in the First Treatment Period

  A participant was considered adherent to denosumab treatment if the participant: - received 2 denosumab injections (overall treatment compliance); - took each injection 6 months (± 4 weeks) apart (treatment compliance over time); - completed the relevant treatment period (treatment persistence). A participant was considered adherent to alendronate treatment if the participant: - took ≥ 80% QW tablets (overall treatment compliance); - took at least 2 tablets in the last month and completed the relevant treatment period (treatment persistence). Participants who did not meet all criteria for their assigned treatment were deemed non-adherent to treatment.

  Treatment period 1 (Month 1 to Month 12)

Secondary Outcomes (17)

• Adherence With Treatment in the Second Treatment Period

  Treatment period 2 (Months 13 to 24)

• Compliance With Treatment in the First Treatment Period

  Treatment period 1 (Month 1 to Month 12)

• Compliance With Treatment in the Second Treatment Period

  Treatment period 2 (Month 13 to Month 24)

• Persistence With Treatment in the First Treatment Period

  Treatment period 1 (Month 1 to Month 12)

• Persistence With Treatment in the Second Treatment Period

  Treatment period 2 (Month 13 to Month 24)

Study Arms (2)

Treatment Sequence B

OTHER

When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment Sequences. Subjects randomized to treatment sequence B will receive 70 mg oral alendronate QW for 1-year (Treatment period 1) followed by denosumab 60 mg Q6M SC for 1 year (Treatment Period 2).

Drug: alendronate; Drug: denosumab

Treatment Sequence A

OTHER

When a subject meets all eligibility criteria and signs the informed consent, they will be randomized in a 1:1 allocation to one of the two treatment sequences. Subjects randomized to treatment sequence A will receive 60 mg denosumab Q6M SC for 1-year (Treatment period 1) followed by oral alendronate 70 mg QW for 1 year (Treatment period 2).

Drug: alendronate; Drug: denosumab

Interventions

alendronate DRUG

Subjects will take 70 mg QW of oral alendronate for 1 year. If a subject is randomized to Treatment Sequence A they will receive alendronate for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive alendronate for 1 year in Treatment Period 1.

Treatment Sequence A; Treatment Sequence B

denosumab DRUG

Subjects will receive 60 mg of denosumab Q6M SC for 1 year. If a subject is randomized to Treatment Sequence A they will receive denosumab for 1 year in Treatment Period 2. If a subject is randomized to Treatment Sequence B they will receive denosumab for 1 year in Treatment Period 1.

Treatment Sequence A; Treatment Sequence B

Eligibility Criteria

• Age: 55 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ambulatory postmenopausal women based on medical history
• \> or = 55 years of age at the start of screening
• Screening bone mineral density (BMD) values (g/cm²), at the lumbar spine OR femoral neck OR total hip that occur within the specified ranges based on the particular scanner that is used. At least 2 lumbar vertebrae must be evaluable by Dual X-ray Absorptiometry (DXA), or at least one hip must be evaluable by DXA
• Provide written informed consent before any study specific procedure is performed.

You may not qualify if:

• Any disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures
• Hyper- or hypothyroidism; however, stable subjects, in the investigator's opinion, on thyroid hormone replacement therapy are allowed
• Current hyper- or hypoparathyroidism
• Current hypo- or hyper calcemia based on the central laboratory reference ranges for albumin-adjusted serum calcium
• Rheumatoid arthritis, Paget's disease, Cushing's disease, hyperprolactinemia, or cirrhosis of the liver
• Any metabolic bone disease, e.g. osteomalacia or osteogenesis imperfecta, which may interfere with the interpretation of the findings
• Any symptomatic vertebral fracture within 3 months prior to screening
• Previous participation in clinical trials with denosumab
• Vitamin D deficiency \[25(OH) vitamin D level \< 20 ng/mL (\<49.9 nmol/L)\]
• Contraindicated to alendronate therapy; contraindications for alendronate therapy include:
• Abnormalities of the esophagus, which delay esophageal emptying such as stricture or achalasia.
• Inability to stand or sit upright for at least 30 minutes.
• Hypersensitivity to alendronate (ALN) or other constituents of ALN tablets.
• Any known prior bisphosphonate use
• Currently enrolled in or has not yet completed at least 1 month since ending other investigational device or drug trail (s), or subject is receiving other investigational agent(s).

Sponsors & Collaborators

• Amgen: lead

Related Publications (4)

• Freemantle N, Satram-Hoang S, Tang ET, Kaur P, Macarios D, Siddhanti S, Borenstein J, Kendler DL; DAPS Investigators. Final results of the DAPS (Denosumab Adherence Preference Satisfaction) study: a 24-month, randomized, crossover comparison with alendronate in postmenopausal women. Osteoporos Int. 2012 Jan;23(1):317-26. doi: 10.1007/s00198-011-1780-1. Epub 2011 Sep 17.

  PMID: 21927922 BACKGROUND

• Kendler DL, Macarios D, Lillestol MJ, Moffett A, Satram-Hoang S, Huang J, Kaur P, Tang ET, Wagman RB, Horne R. Influence of patient perceptions and preferences for osteoporosis medication on adherence behavior in the Denosumab Adherence Preference Satisfaction study. Menopause. 2014 Jan;21(1):25-32. doi: 10.1097/GME.0b013e31828f5e5d.

  PMID: 23676636 BACKGROUND

• Kendler DL, McClung MR, Freemantle N, Lillestol M, Moffett AH, Borenstein J, Satram-Hoang S, Yang YC, Kaur P, Macarios D, Siddhanti S; DAPS Investigators. Adherence, preference, and satisfaction of postmenopausal women taking denosumab or alendronate. Osteoporos Int. 2011 Jun;22(6):1725-35. doi: 10.1007/s00198-010-1378-z. Epub 2010 Sep 9.

  PMID: 20827547 BACKGROUND

• Kendler D, Chines A, Clark P, Ebeling PR, McClung M, Rhee Y, Huang S, Stad RK. Bone Mineral Density After Transitioning From Denosumab to Alendronate. J Clin Endocrinol Metab. 2020 Mar 1;105(3):e255-64. doi: 10.1210/clinem/dgz095.

  PMID: 31665314 DERIVED

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Osteoporosis; Bone Diseases, Metabolic; Personal Satisfaction

Interventions

Alendronate; Denosumab

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 20, 2007
• Study Start: September 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2010
• Last Updated: December 3, 2019
• Results First Posted: January 7, 2014

Record last verified: 2019-12