Study of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (MK-0217A-329)

• Sponsor: Organon and Co (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01437111
• Collaborator: (none)
• Enrollment: 200
• Arm: 1
• Actual Duration (Months): 13.3

Study Details

Study Description

Brief Summary

This study will assess the effect of 26 weeks of once-weekly treatment with MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) on serum levels of 25-hydroxyvitamin D [25(OH)D].

Condition or Disease	Intervention/Treatment	Phase
Osteoporosis	Drug: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 200 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase III (Phase IV Program) Open-Label, Multicenter Clinical Trial in Thailand to Study the Effect of MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet (Fosamax Plus 70/5600) for 6 Months on 25-Hydroxyvitamin D Levels in the Treatment of Osteoporosis in Postmenopausal Women and Men
• Actual Study Start Date: Oct 26, 2011
• Actual Primary Completion Date: Dec 5, 2012
• Actual Study Completion Date: Dec 5, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fosamax Plus Calcium supplement (elemental calcium and/or calcium carbonate) without vitamin D will also be supplied to participants	Drug: MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet; One combination tablet orally once a week; Other Names: Fosamax Plus 70/5600

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26 [Week 26]

   Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study.

Secondary Outcome Measures

1. Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26 [Baseline and Week 26]

   Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Man aged 50 or older, or a woman who is postmenopausal on day of signing informed consent or has been menopausal for at least one year

• Meets bone mineral density (BMD) criteria

• Agree to discontinue any osteoporosis drug treatment for duration of study

Exclusion Criteria:

• Any contraindication to alendronate and vitamin D

• Not ambulatory

• Has received treatment with any anabolic steroid agent within the past 12 months, systemic glucocorticoids, for more than 2 weeks in the past 6 months, current use of immunosuppressants, fluoride treatment at a dose greater than 1 mg/day for more than 2 weeks within the past 3 months, treated with parathyroid hormone (PTH) for more than 2 weeks within the past 3 months, current use of chemotherapy or heparin, use of growth hormone for more than 2 weeks within the past 6 months, use of active hormonal vitamin D analogs in the past 2 months, current use of vitamin A >10,000 IU daily, current use of, lithium, or anti-convulsants including barbiturates, hydantoins, and carbamazepine, current use of calcium supplement in amount excess of 1500 mg daily, and/or current use of Vitamin D supplement

• History of malignancy <5 years, except adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer

• One or more of the following concomitant conditions: Upper gastrointestinal (GI) disorders not adequately controlled; myocardial infarction, unstable angina, stroke and revascularization condition within 3 months; malabsorption syndrome; primary or secondary hyperparathyroidism not adequately treated; thyroid disease not adequately controlled; severe renal insufficiency; uncontrolled genitourinary, cardiovascular, hepatic, renal, endocrine, hematologic, neurological, psychiatric, or pulmonary diseases; uncontrolled hypertension; new onset diabetes (within 3 months), poorly controlled hyperglycemia, or hypoglycemia for any cause; evidence for metabolic bone disease other than osteoporosis; abnormal indices of calcium metabolism; and/or active renal stone disease

• User of illicit recreational drugs or has had a recent history (within the last year) of drug or alcohol abuse or dependence

• Heavy consumer of alcohol or alcohol containing products.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Organon and Co

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Organon and Co
• ClinicalTrials.gov Identifier: NCT01437111
• Other Study ID Numbers: 0217A-329
• First Posted: Sep 20, 2011
• Last Update Posted: Feb 8, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Organon and Co: Osteoporosis; Postmenopausal
• Additional relevant MeSH terms: Osteoporosis; Vitamin D; Cholecalciferol; Alendronate

Study Results

Participant Flow

Arm/Group Title	Fosamax Plus: All Participants
Arm/Group Description	All participants who were enrolled in the study to receive one oral combination tablet of Fosamax Plus weekly.
Period Title: Overall Study
STARTED	200
Treated Participants	198
COMPLETED	182
NOT COMPLETED	18

Baseline Characteristics

Arm/Group Title	Fosamax Plus: All Treated Participants
Arm/Group Description	All participants who received at least one oral dose combination tablet of Fosamax Plus.
Overall Participants	198
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	68.81 (8.39)
Sex: Female, Male (Count of Participants)
Female	193 97.5%
Male	5 2.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Serum 25-hydroxyvitamin D >=50 ng/mL at Week 26
Description	Serum samples to measure serum 25-hydroxyvitamin D [25(OH)D] will be collected at specific visits during the treatment phase of the study.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

Full Analysis Set (FAS) consisted of participants who received >=1 dose of study drug; had >=1 post-baseline observation for the analysis endpoint; and had baseline data. For analysis, participants in the FAS were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve

Arm/Group Title	Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline	Fosamax Plus: Other Osteoporosis Therapy at Baseline	Fosamax Plus: Treatment Naive at Baseline	Fosamax Plus: All Treated Participants
Arm/Group Description	Participants receiving recent/current osteoporosis therapy at baseline (including bisphosphonate, strontium, estrogen, or SERM were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.	Participants receiving other osteoporosis drugs at baseline (besides bisphosphonate, strontium, estrogen, or SERM) were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.	Participants that were treatment-naïve or not recently treated at baseline were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.	All participants who received at least one oral dose combination tablet of Fosamax Plus.
Measure Participants	28	64	94	186
Number [Participants]	1 0.5%	3 NaN	1 NaN	5 NaN

2. Secondary Outcome

Title	Mean Percent Change From Baseline of Bone Resorption Marker of Serum Beta-CrossLaps at Week 26
Description	Serum samples for Beta-CrossLaps (β-CTx) will be collected at specific visits during the treatment phase of the study.
Time Frame	Baseline and Week 26

Outcome Measure Data

Analysis Population Description

Per Protocol Population consisted of FAS but excluded participants who had important deviations from protocol or did not complete study on study drug. For analysis, participants in Per Protocol Population were categorized into 3 subgroups by osteoporosis therapy received at baseline: Recent/Current, Other therapy, and Treatment Naïve.

Arm/Group Title	Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline	Fosamax Plus: Other Osteoporosis Therapy at Baseline	Fosamax Plus: Treatment Naive at Baseline	Fosamax Plus: All Treated Participants
Arm/Group Description	Participants receiving recent/current osteoporosis therapy at baseline (including bisphosphonate, strontium, estrogen, or SERM were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.	Participants receiving other osteoporosis drugs at baseline (besides bisphosphonate, strontium, estrogen, or SERM) were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.	Participants that were treatment-naïve or not recently treated at baseline were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.	All participants who received at least one oral dose combination tablet of Fosamax Plus.
Measure Participants	28	62	92	182
Mean (Standard Deviation) [Percent change]	-12.65 (56.94)	-49.82 (35.08)	-76.81 (20.33)	-57.74 (40.34)

Adverse Events

Time Frame	Up to Week 26
Adverse Event Reporting Description	Of 200 participants enrolled in the study, two participants did not receive treatment and were not evaluated for safety.
Arm/Group Title	Fosamax Plus: All Treated Participants
Arm/Group Description	All participants who received at least one oral dose combination tablet of Fosamax Plus.
All Cause Mortality
	Fosamax Plus: All Treated Participants
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fosamax Plus: All Treated Participants
	Affected / at Risk (%)	# Events
Total	4/198 (2%)
Gastrointestinal disorders
Dyspepsia	1/198 (0.5%)	1
Metabolism and nutrition disorders
Hyponatraemia	1/198 (0.5%)	1
Musculoskeletal and connective tissue disorders
Femur fracture	1/198 (0.5%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm, malignant stage, unspecified	1/198 (0.5%)	1
Other (Not Including Serious) Adverse Events
	Fosamax Plus: All Treated Participants
	Affected / at Risk (%)	# Events
Total	10/198 (5.1%)
Infections and infestations
Upper respiratory tract infection	10/198 (5.1%)	10

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Investigators agreed to allow the Sponsor to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Investigators have also agreed that any information identified by the SPONSOR as confidential must be deleted prior to submission.