OsteoporosisPhase 1NCT00803790

A Study of the Bioequivalence of 70-mg Alendronate and 70-mg Alendronate in Combination With 5600 IU Vitamin D (MK0217A-253)

A Phase 1 study testing alendronate sodium+vitamin D combination, Comparator: alendronate and Comparator: Vitamin D in people with Osteoporosis, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the bioequivalence of alendronate in combination with vitamin D compared to alendronate alone and the bioequivalence of vitamin D in combination with alendronate compared to vitamin D alone. This was an open-label, randomized, 2-part, crossover study. Read more about this study

Who is it for?: Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Osteoporosis
What is being tested?: alendronate sodium+vitamin D combination, Comparator: alendronate and Comparator: Vitamin D
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 318 participants
Where: No sites listed yet
Study dates: May 2006to Jul 2006
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male or nonpregnant female age 18 to 85 years
female of childbearing potential on appropriate method of contraception and not nursing
Body Mass Index (BMI) less than or equal to 30 kg/m2
subject is in good health

Who cannot join

mental or legal incapacitation
received bisphosphonate treatment within 3 months of enrollment.
unable to sit or stand upright for at least 2 hours
unwilling to refrain from consumption of alcohol or caffeinated products from 24 hours prior and 36 hours after study drug administration
unwilling to limit alcohol consumption to no more than 2 drinks per day
unwilling to limit caffeinated products to the equivalent of 4 cups of coffee per day or equivalent.
unwilling to refrain from smoking during the study

About this study

Official title: A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70-mg Alendronate/5600 IU Vitamin D3 Final Market Combination Tablet to a 70-mg Alendronate Marketed Tablet, and the Relative Bioavailability of Vitamin D3

This was an open-label, randomized, 2-part, crossover study. Each participant participated in one part of the study only (i.e., each participant participated only in Part I or only in Part II). Participants entered the study sequentially within each part of the study. A washout of at least 12 days separated each treatment period within each part of the study.

Conditions: Osteoporosis
Being tested: alendronate sodium+vitamin D combination, Comparator: alendronate, Comparator: Vitamin D
Medical subject headings: Osteoporosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

alendronate sodium+vitamin D combinationDrug
A single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence.
Comparator: alendronateDrug
A single dose tablet of 70mg alendronate in one treatment period of each sequence.
Comparator: Vitamin DDietary supplement
Two tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence.

Study groups in NCT00803790
Study group	Role	What they receive
Sequence 1- alendronate+vitamin D combination then alendronate	Experimental	Participants in Part 1 received 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period. Receives: Drug: alendronate sodium+vitamin D combination; Drug: Comparator: alendronate
Sequence 2 alendronate then alendronate+vitamin D combination	Experimental	Participants in Part 1 received 70mg alendronate tablet in Period 1 followed by 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period. Receives: Drug: alendronate sodium+vitamin D combination; Drug: Comparator: alendronate
Sequence 3 alendronate+vitamin D combination then vitamin D	Experimental	Participants in Part 2 received 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period. Receives: Drug: alendronate sodium+vitamin D combination; Dietary Supplement: Comparator: Vitamin D
Sequence 4- vitamin D then alendronate+vitamin D combination	Experimental	Participants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period. Receives: Drug: alendronate sodium+vitamin D combination; Dietary Supplement: Comparator: Vitamin D

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 1: Urinary Excretion of Alendronate
Bioequivalence was demonstrated by measuring the total urinary excretion of alendronate which was determined over a 36-hour period following single dose administration of 70-mg alendronate+5600 International Units (IU) vitamin D combination tablet and 70mg alendronate tablet alone. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose on Days 1 and 2.
Measured: Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2)
Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D
The serum vitamin D pharmacokinetic parameter was calculated following the treatment of 70mg alendronate+5600 IU vitamin D combination tablet and 5600 IU vitamin D tablet on Day 1: area under the plasma concentration-time curve (AUC0-80hr). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.
Measured: Day 1 across the 80-hour plasma collection period (Period 1 and 2)

Secondary outcomes (1)

Part II : Maximum Concentration (Cmax) of Vitamin D
Serum vitamin D pharmacokinetic parameter was calculated for the following: maximum concentration of drug observed in serum (Cmax). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.
Measured: Day 1 across the 80-hour plasma collection period (Periods 1 and 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Jul 2006

First posted8 Dec 2008 (estimated)
Study startMay 2006
Primary completionJul 2006
Study completionJul 2006

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for OsteoporosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 318 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00803790
Sponsor's protocol ID: 0217A-253
Other IDs: 2008_595
Status last verified: Feb 2022
First submitted: 4 Dec 2008
Last updated: 3 Feb 2022
Results posted: Yes, on ClinicalTrials.gov

Publications

Denker AE, Lazarus N, Porras A, Ramakrishnan R, Constanzer M, Scott BB, Chavez-Eng C, Woolf E, Maganti L, Larson P, Gottesdiener K, Wagner JA. Bioavailability of alendronate and vitamin D(3) in an alendronate/vitamin D(3) combination tablet. J Clin Pharmacol. 2011 Oct;51(10):1439-48. doi: 10.1177/0091270010382010. Epub 2010 Dec 8.
PubMed 21148044

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 2-Part, Open-Label, Randomized, Crossover Study to Evaluate the Bioequivalence of the 70-mg Alendronate/5600 IU Vitamin D3 Final Market Combination Tablet to a 70-mg Alendronate Marketed Tablet, and the Relative Bioavailability of Vitamin D3
ClinicalTrials.gov ID: NCT00803790
Acronym / sponsor ID: 0217A-253
Conditions: Osteoporosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 318 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Jul 2006 (actual)
Study completion: Jul 2006 (actual)
First posted: 8 Dec 2008 (estimated)
Results: Posted 9 May 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Sequence 1- alendronate+vitamin D combination then alendronate	Experimental	Drug: alendronate sodium+vitamin D combination, Drug: Comparator: alendronateParticipants in Part 1 received 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period.
Sequence 2 alendronate then alendronate+vitamin D combination	Experimental	Drug: alendronate sodium+vitamin D combination, Drug: Comparator: alendronateParticipants in Part 1 received 70mg alendronate tablet in Period 1 followed by 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
Sequence 3 alendronate+vitamin D combination then vitamin D	Experimental	Drug: alendronate sodium+vitamin D combination, Dietary Supplement: Comparator: Vitamin DParticipants in Part 2 received 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period.
Sequence 4- vitamin D then alendronate+vitamin D combination	Experimental	Drug: alendronate sodium+vitamin D combination, Dietary Supplement: Comparator: Vitamin DParticipants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or nonpregnant female age 18 to 85 years
female of childbearing potential on appropriate method of contraception and not nursing
Body Mass Index (BMI) less than or equal to 30 kg/m2
subject is in good health

Key exclusion criteria (7 listed)

mental or legal incapacitation
received bisphosphonate treatment within 3 months of enrollment.
unable to sit or stand upright for at least 2 hours
unwilling to refrain from consumption of alcohol or caffeinated products from 24 hours prior and 36 hours after study drug administration
unwilling to limit alcohol consumption to no more than 2 drinks per day

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
alendronate sodium+vitamin D combinationA single dose tablet of 70mg alendronate sodium+5600 IU vitamin D combination tablet in one treatment period of each sequence.	Drug	Sequence 1- alendronate+vitamin D combination then alendronate, Sequence 2 alendronate then alendronate+vitamin D combination, Sequence 3 alendronate+vitamin D combination then vitamin D, Sequence 4- vitamin D then alendronate+vitamin D combination
Comparator: alendronateA single dose tablet of 70mg alendronate in one treatment period of each sequence.	Drug	Sequence 1- alendronate+vitamin D combination then alendronate, Sequence 2 alendronate then alendronate+vitamin D combination
Comparator: Vitamin DTwo tablets of 2800 IU vitamin D, totaling 5600 IU, in one treatment period of each sequence.	Dietary supplement	Sequence 3 alendronate+vitamin D combination then vitamin D, Sequence 4- vitamin D then alendronate+vitamin D combination

Primary outcome

Part 1: Urinary Excretion of Alendronate
Time frame: Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2)
Bioequivalence was demonstrated by measuring the total urinary excretion of alendronate which was determined over a 36-hour period following single dose administration of 70-mg alendronate+5600 International Units (IU) vitamin D combination tablet and 70mg alendronate tablet alone. Urine for each treatment period was collected at -2 to 0 hours predose, 0 to 8, 8 to 24, and 24 to 36 hours postdose on Days 1 and 2.
Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D
Time frame: Day 1 across the 80-hour plasma collection period (Period 1 and 2)
The serum vitamin D pharmacokinetic parameter was calculated following the treatment of 70mg alendronate+5600 IU vitamin D combination tablet and 5600 IU vitamin D tablet on Day 1: area under the plasma concentration-time curve (AUC0-80hr). Serum samples for determination of vitamin D concentrations were obtained at -2 and 0 hrs predose on Day 1 and at 2, 3, 5, 7, 9, 12, 16, 24, 36, 48, 72 and 80 hours post dose for each treatment period.

1 secondary outcome

Part II : Maximum Concentration (Cmax) of Vitamin D
Time frame: Day 1 across the 80-hour plasma collection period (Periods 1 and 2)

Results and safety

Results posted to the registry on 9 May 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Part 1 Alendronate+Vitamin D Combo, Then Alendronate	125	116
Part 1 Alendronate, Then Alendronate+Vitamin D Combo	126	114
Part 2 Alendronate+Vitamin D Combo, Then Vitamin D	32	31
Part 2 Vitamin D, Then Alendronate+Vitamin D Combo	35	31

Primary outcome: Part 1: Urinary Excretion of Alendronate

Time frame: Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2). Least squares mean (Standard Deviation). Unit: μg

Measure	Alendronate+Vitamin D Combo n = 220	Alendronate n = 220
Value	133.6 (189.2)	132.2 (273.4)

Alendronate+Vitamin D Combo vs Alendronate: least square mean ratio: 1.01 (90% CI 0.92 to 1.11)

Population analysed: 220 participants of the 251 enrolled in Part 1 were included in the statistical analysis. 31 participants were excluded: 23 were enrolled but did not complete both study periods and 8 participants had incomplete urine profiles in one or both periods.

Primary outcome: Part II: AUC (Area Under the Plasma Concentration-time Curve) of Vitamin D

Time frame: Day 1 across the 80-hour plasma collection period (Period 1 and 2). Least squares mean (Standard Deviation). Unit: ng*hr/mL

Measure	Alendronate+Vitamin D Combo n = 60	Vitamin D n = 60
Value	490.2 (259.6)	518.7 (269.8)

Alendronate+Vitamin D Combo vs Vitamin D: Least Square Mean Ratio: 0.94 (90% CI 0.89 to 1.00)

Population analysed: 60 participants of the 67 enrolled in Part 2 were included in the statistical analysis. 7 participants that were enrolled, but did not complete both study periods were excluded.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alendronate+Vitamin D Combo	0 of 302 (0%)	21 of 302 (7%)	Not reported
Alendronate	0 of 241 (0%)	12 of 241 (5%)	Not reported
Vitamin D	0 of 65 (0%)	9 of 65 (13.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21148044Denker AE, Lazarus N, Porras A, Ramakrishnan R, Constanzer M, Scott BB, Chavez-Eng C, Woolf E, Maganti L, Larson P, Gottesdiener K, Wagner JA. Bioavailability of alendronate and vitamin D(3) in an alendronate/vitamin D(3) combination tablet. J Clin Pharmacol. 2011 Oct;51(10):1439-48. doi: 10.1177/0091270010382010. Epub 2010 Dec 8.

Related trials for Osteoporosis

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing alendronate sodium+vitamin D combination, Comparator: alendronate and Comparator: Vitamin D in people with Osteoporosis, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Urinary Excretion of Alendronate (time frame: Day 1-2 across the 36 hour urinary collection period (Periods 1 and 2)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00803790, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.