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CompletedNCT00729651Updated Apr 23, 2024Results posted

Efficacy and Safety Study of Fosamax Plus D in Postmenopausal Women With Osteoporosis (0217A-263)

A Phase 4 interventional study of alendronate sodium (+) cholecalciferol and Comparator: Alendronate sodium (Fosamax) in Osteoporosis Postmenopausal, sponsored by Organon and Co. Completed. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-23.

Sponsored by Organon and Co · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2008, registered Aug 2008).
Phase
Phase 4
Study type
Interventional
Enrollment
343
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

To demonstrate the efficacy/safety of Fosamax Plus D

02

Conditions studied

  • Osteoporosis Postmenopausal
03

In context

Osteoporosis, Postmenopausal

337 studies on the registry are indexed under Osteoporosis, Postmenopausal; 29 are open to participants now.

This study's enrollment of 343 is above the median of 110 across 265 interventional studies indexed under Osteoporosis, Postmenopausal.

Browse Osteoporosis, Postmenopausal studies →

Lead sponsor

Organon and Co is the lead sponsor of 505 studies on the registry; none are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 18 (82%) have results posted.

Browse Organon & Co. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient agrees to apply sunscreen and limit sunlight-exposure to 1 hour per day during the study
  • Patient has been diagnosed with osteoporosis
  • Patient has been postmenopausal for more than 6 months
  • Patient has no contraindication to taking oral bisphosphonates
  • Patient is eligible for dual energy x-ray absorptiometry in spine or hip

Exclusion criteria

Exclusion Criteria:

  • Patients with esophageal dysfunction
  • Patients who can not sit or stand at least 30 minutes
  • Patients who had a malignant disease or active systemic disease 5 years prior to participating in this trial
  • Patients with diseases of bone or mineral metabolism besides osteoporosis or receiving therapies which affect bone metabolism or calcium metabolism
  • Patients with history of major gastrointestinal disease (peptic ulcer, malabsorption, esophageal disease, gastritis, gastroduodenitis, etc.) within the last 6 months
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
343 participants (actual)

Study arms

  • Experimental
    1

    Alendronate sodium/Cholecalciferol

    Drug: alendronate sodium (+) cholecalciferol · Dietary Supplement: Comparator: Calcium

  • Active comparator
    2

    Alendronate sodium

    Drug: Comparator: Alendronate sodium (Fosamax) · Dietary Supplement: Comparator: Calcium

Interventions

  • Drugalendronate sodium (+) cholecalciferol

    Alendronate sodium/Cholecalciferol; tablet, once weekly, for 16 weeks

    Also known as: Fosamax Plus D

  • DrugComparator: Alendronate sodium (Fosamax)

    Alendronate sodium; tablet, once weekly, for 16 weeks

  • Dietary supplementComparator: Calcium

    500 mg oral tablet calcium once daily, for 16 weeks

06

What researchers measure

Primary outcomes

  1. Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment

    Time frame: 16 weeks

Secondary outcomes

  1. Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment

    Time frame: Baseline and 16 weeks

07

Results

Posted Apr 2, 2010

Participant flow

17 centers participated in this study (11 - Medical Center of the University, 7 - General Hospital). FPE(First patient enrolled) : March-2008, FPI(First patient in) : April-2008, LPO(Last patient out) : April-2009.

Participant flow — Overall Study
MilestoneFosamax Plus DFosamax
Started173170
Completed154152
Not completed1918
Withdrew: Withdrawal by subject56
Withdrew: Lost to follow-up54
Withdrew: Protocol violation01
Withdrew: Adverse event73
Withdrew: Visit 3, 25 ohd level ≤9 ng/ml04
Withdrew: Subject's private reason20

Outcome measures

PrimaryPatients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment
Time frame:
16 weeks
Reported as:
Number · participants
Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Below the Deficiency Level (Less Than 15 ng/ml) at 16 Weeks of Treatment
participantsFosamax Plus DFosamax
With Vitamin D Deficiency255
Without Vitamin D Deficiency13477
Statistical analysis
  • Fosamax Plus D vs Fosamax · Cochran-Mantel-Haenszel · p = <0.0001 · Odds ratio (or): 0.02 · 95% CI 0.00 to 0.08Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects' proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.
SecondarySerum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment
Time frame:
Baseline and 16 weeks
Reported as:
Least squares mean · Percentage Change Serum PTH
Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment
Percentage Change Serum PTHFosamax Plus DFosamax
Serum PTH (Parathyroid Hormone) Percentage Changes From Baseline to 16 Weeks of Treatment8.17 (-3.24 to 19.58)29.98 (18.34 to 41.62)
Statistical analysis
  • Fosamax Plus D vs Fosamax · ANCOVA · p = 0.0091Least squares mean is mean of serum PTH percentage changes adjusted serum PTH level at baseline.
Post-hocPatients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment
Time frame:
16 weeks
Reported as:
Number · participants
Patients With Serum 25 OHD (Serum 25-hydroxyvitamin D) Less and Greater Than 20 ng/ml at 16 Weeks of Treatment
participantsFosamax Plus DFosamax
With 25 OHD < 20ng/ml at 16 weeks of treatment793
With 25 OHD >= 20ng/ml at 16 weeks of treatment12939
Statistical analysis
  • Fosamax Plus D vs Fosamax · Cochran-Mantel-Haenszel · p = <0.0001 · Odds ratio (or): 0.02 · 95% CI 0.01 to 0.04Mantel-Haenszel estimator of the common odds ratio was calculated by using Cochran-Mantel-Haenszel test for subjects' proportions with vitamin D deficiency changes at 16 weeks (visit 4) from baseline (visit 1) between treatment groups.
Post-hocMean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment
Time frame:
16 weeks
Reported as:
Mean · ng/ml
Mean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment
ng/mlFosamax Plus DFosamax
Mean Serum 25 OHD(Serum 25-hydroxyvitamin D) at 16 Weeks of Treatment30.08 ± 5.8717.14 ± 6.04

Adverse events

Collected over Adverse events were followed up until 14 days after the last dose of investigational drug.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fosamax Plus D—7/171 (4.1%)60/171 (35.1%)
Fosamax—1/170 (0.6%)55/170 (32.4%)
Most frequent serious events
Showing 10 of 11
Most frequent serious events
EventFosamax Plus DFosamax
OsteochondrosisMusculoskeletal and connective tissue disorders0/1711/170
Herpes zosterInfections and infestations1/1710/170
Lung abscessInfections and infestations1/1710/170
Otitis mediaInfections and infestations1/1710/170
PneumoniaInfections and infestations1/1710/170
MyalgiaMusculoskeletal and connective tissue disorders1/1710/170
PyrexiaGeneral disorders1/1710/170
Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/1710/170
Cerebrovascular accidentNervous system disorders1/1710/170
CystoceleReproductive system and breast disorders1/1710/170
Most frequent other events
Showing 10 of 66
Most frequent other events
EventFosamax Plus DFosamax
DyspepsiaGastrointestinal disorders11/17118/170
MyalgiaMusculoskeletal and connective tissue disorders7/17111/170
NasopharyngitisInfections and infestations8/1718/170
Back painMusculoskeletal and connective tissue disorders6/1711/170
ArthralgiaMusculoskeletal and connective tissue disorders4/1713/170
HeadacheNervous system disorders4/1712/170
Epigastric discomfortGastrointestinal disorders2/1713/170
Musculoskeletal painMusculoskeletal and connective tissue disorders1/1713/170
Upper respiratory tract infectionInfections and infestations0/1713/170
NauseaGastrointestinal disorders3/1711/170

Baseline characteristics

Age, Continuous
Age, Continuous(years)Fosamax Plus DFosamaxTotal
Mean64.59 ± 7.0965.31 ± 7.6264.94 ± 7.36
Age, Customized
Age, Customized(participants)Fosamax Plus DFosamaxTotal
<=44 years of age000
45-49 years of age101
50-59 years of age474390
60-69 years of age8573158
70-79 years of age375188
>=80 years of age336
Sex: Female, Male
Sex: Female, Male(Participants)Fosamax Plus DFosamaxTotal
Female173170343
Male000
Patients with/without Vitamin D deficiency
Patients with/without Vitamin D deficiency(participants)Fosamax Plus DFosamaxTotal
With Vitamin D deficiency at baseline5756113
Without Vitamin D deficiency at baseline116114230
T-score classification by inclusion criteria: A fracture in spine Lumbar 1-4 and T-score ≤ -2.0]
T-score classification by inclusion criteria: A fracture in spine Lumbar 1-4 and T-score ≤ -2.0](Participants)Fosamax Plus DFosamaxTotal
A fracture in spine Lumbar 1-4 and T-score ≤ -2.09514
Not Applicable164165329
T-score classification by inclusion criteria: Femoral neck T-score ≤ -2.5
T-score classification by inclusion criteria: Femoral neck T-score ≤ -2.5(Participants)Fosamax Plus DFosamaxTotal
Femoral neck T-score ≤ -2.54358101
Not Applicable130112242
T-score classification by inclusion criteria: Femoral total T-score ≤ -2.5
T-score classification by inclusion criteria: Femoral total T-score ≤ -2.5(Participants)Fosamax Plus DFosamaxTotal
Femoral total T-score ≤ -2.5202545
Not Applicable153145298
T-score classification by inclusion criteria: Spine (average of spine Lumbar 1-4 ) T-score ≤-2.5
T-score classification by inclusion criteria: Spine (average of spine Lumbar 1-4 ) T-score ≤-2.5(Participants)Fosamax Plus DFosamaxTotal
Spine (average of spine Lumbar 1-4 ) T-score ≤-2.5144132276
Not Applicable293867

11 further baseline measures are reported on the registry.

08

Study locations

No study locations are listed for this record.

09

References and documents

Publications

  • Kim KJ, Min YK, Koh JM, Chung YS, Kim KM, Byun DW, Kim IJ, Kim M, Kim SS, Min KW, Han KO, Park HM, Shin CS, Choi SH, Park JS, Chung DJ, Mok JO, Baek HS, Moon SH, Kim YS, Lim SK; VALUE study group. Efficacy and safety of weekly alendronate plus vitamin D(3) 5600 IU versus weekly alendronate alone in Korean osteoporotic women: 16-week randomized trial. Yonsei Med J. 2014 May;55(3):715-24. doi: 10.3349/ymj.2014.55.3.715. Epub 2014 Apr 1. PubMed 24719139 ↗

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2008 to primary completion in Apr 2009, 12 months.

Results were first posted in Apr 2010, 11 months after primary completion.

Of 26 phase 4 interventional studies under Osteoporosis, Postmenopausal, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 66. This study's 12 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 5, 2008
First posted
Aug 7, 2008
StartActual
Mar 20, 2008
Primary completionActual
Apr 10, 2009
CompletionActual
Apr 10, 2009
Results first posted
Apr 2, 2010
Last update
Apr 23, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00729651
Lead sponsor
Organon and Co
Responsible party
Sponsor
First posted
Aug 7, 2008
Start date
Mar 20, 2008
Primary completion
Apr 10, 2009
Completion
Apr 10, 2009
Results posted
Apr 2, 2010
Last update
Apr 23, 2024

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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