US Pharm. 2012;37(9):37-43.
The National Osteoporosis Foundation (NOF) defines
adequate amounts of calcium and vitamin D to be at least 1,200 mg and
800 to 1,000 IU per day, respectively, for men and postmenopausal women
50 years and older.1 Men and women who are not receiving
adequate amounts of calcium and vitamin D supplementation are at an
increased risk of osteoporosis and fractures.1 Despite an
established recommended daily amount of adequate supplementation intake,
many women do not understand the importance of such supplementation. A
meta-analysis by Sunyecz and Weisman concluded that women did not take
the recommended amounts of calcium and vitamin D despite advancements in
osteoporosis treatments and medication.2
Additional issues with calcium supplementation exist due
to the type of calcium salt utilized. Calcium supplementation is
available as two salt forms, calcium carbonate and calcium citrate, and
the pharmacokinetic profile differs for each. The citrate formulation is
best absorbed in a basic environment; thus, it is the preferred salt if
the patient is on either an H2-antagonist or a proton pump inhibitor (PPI).
Vitamin D sources exist inside and outside the human body.
Vitamin D is a fat-soluble vitamin obtained from a few plant sources
and supplementation and is also synthesized in the skin from sun
exposure.3 Ergocalciferol (D2) is made from plant sterols and yeast, whereas cholecalciferol (D3) is synthesized in the skin by ultraviolet rays via 7-dehydrocholesterol.4
In both instances, vitamin D is acquired in its inactive form and has
to be activated once in the body. The liver converts vitamin D to
25-hydroxyvitamin D (25[OH]D), known as calcidiol. Further
activation then occurs in the kidney, where it forms the physiologically
active formulation 1,25-dihydroxyvitamin D (1,25-[OH]2D), or calcitrol.3 Without this activation process, any formulation of calcium cannot be absorbed.
Osteoporosis screening and diagnosis are conducted by
measuring bone mineral density (BMD). This procedure tests the risk of
bone fracture; it can also indicate improvements or deterioration in BMD
and may be used in monitoring osteoporosis therapy.1 There
are two areas where BMD is measured: central (spine and hip) and
peripheral (forearm, heel, fingers) skeletal sites. This test is
accurate and highly reproducible when performed according to accepted
standards. According to the World Health Organization (WHO) diagnostic
classification, peripheral dual-energy x-ray absorptiometry (pDXA) is
not appropriate for monitoring BMD after treatment.1 However,
recent data suggest that “peripheral bone density testing in the
primary care setting can also identify postmenopausal women who have a
higher risk for fracture over the short term (1 year).”5 BMD
testing may be needed for a minimum of 2 years to measure any change.
Repeated screenings can be used in older women, those with lower BMD at
baseline, and those with other risk factors for fracture.5
Previous studies have indicated that community pharmacists
have the opportunity for, and are beneficial to the community in,
screening, educating, and referring women at risk of osteoporosis.6,7 A recent article published in Osteoporosis International
reported that interventions by health care professionals improved
patients’ quality of life, medication compliance, and calcium intake,
but the data were less conclusive of the effects of such intervention on
BMD. It concluded that further research is needed to assess the
outcomes of nondrug interventions by health care professionals on
certain osteoporotic women.8
The following study intends to show the positive impact a
pharmacist can make when asking questions and counseling patients on
calcium and vitamin D supplementation in the community pharmacy setting.
The primary objective of this study was to identify women
at risk for osteoporosis or on bisphosphonate therapy who were not
taking recommended amounts of calcium and vitamin D supplementation.
Secondary objectives included: 1) assessing efficacy of appropriate
supplementation by measuring BMD at baseline, 3 months, and 6 months;
and 2) participant satisfaction and the value of a community
pharmacist’s role in increasing or modifying supplementation intake and
thus increasing BMD.
The Institutional Review Board (IRB) approved this study,
and informed consent was obtained from each participant. Participants
were identified at two community pharmacies and two senior centers
located in multiple regions of Massachusetts. Participants in each
community pharmacy were identified using a real-time computer profile
search and then approached by the use of an informational flyer
explaining the study that was stapled on each prescription for a
bisphosphonate or prednisone. Participants were also asked, upon
prescription pick-up, if they would like to participate in the research
study by the primary investigator (PI) or PharmD candidate. Another
method of recruitment was by questioning women during counseling for any
prescription or OTC products, in particular those seeking calcium and
vitamin D supplementation. The PI also recruited participants during a
one-on-one medication review session at two area senior centers.
Participants were identified if on bisphosphonate treatment and/or
long-term corticosteroid therapy based on a “medication brown bag”
Inclusion criteria were based on the following: 1) women
on bisphosphonate treatment (i.e., alendronate sodium, risedronate
sodium, ibandronate sodium); and/or 2) women on long-term corticosteroid
therapy (daily dose >5 mg prednisone or equivalent for >3
months). Women over the age of 18 years with documented history of
long-term prednisone therapy were included in the study due to the
association of low bone mass and risk of osteoporosis. Participants
under 50 years of age were included in the study to potentially benefit
from osteoporosis prevention education.
Exclusion criteria were based on the following: 1) women
under the age of 18 years; 2) any allergies or contraindications to
either supplement; 3) a history of calcium-based kidney stones; and 4)
previous or current gastrointestinal problems with taking
supplementation and/or bisphosphonates because of the possibility of
worsening or recurrence of such issues. Participants were also excluded
and referred to their primary care physician if their initial BMD test
resulted in a T-score of ≤-2.5 without prior diagnosis of osteoporosis (TABLE 1).
All participants were asked to provide demographic
information (telephone number, age, gender), current and past medical
history, and medication history, including specific information on
calcium and vitamin D intake (TABLE 2). At the initial visit,
recruited participants were provided with educational material on
osteoporosis and were reviewed by the PI. Participants were then advised
of the appropriate amounts and types of calcium and vitamin D based on
the participant’s age and medications. This document was used to record
the initial BMD result and was used again at 3 months and 6 months to
record supplementation intake as well as BMD measurement (TABLE 3). A BMD measurement was taken at peripheral skeletal sites (heel) using the Sahara Clinical Bone Sonometer (Hologic, Inc.).
Last, participants were prompted to assess their overall
satisfaction with the service provided through a short survey at 6
months. Participants were asked to use a Likert (five-level) scale in
answering 6 questions (FIGURE 1).
Sample size was determined using the primary outcome
involving the percentage of identified participants who were not
appropriately using calcium and vitamin D supplementation. Since this
percentage was unknown for the different sites, the assumed value of 50%
was used. It was believed that this rate could be reduced to 25% as a
result of education from the pharmacist-participant interaction. The
number of participants required to detect this 25% difference at the 5%
level of significance with 80% power was 30 participants.9 A total of 36 participants were to be recruited to account for possible dropouts.
Participant demographics, other health-related variables,
and satisfaction survey results were summarized using descriptive
statistics (including means and percentages). The McNemar test for
categorical variables and paired t-tests for numerical variables
were used to examine the effect of education from the
pharmacist-participant interaction on appropriate calcium/vitamin D
supplementation and BMD results at baseline, 3 months, and 6 months.
Results were considered statistically significant if the observed level
of significance is P <.05. All analyses were conducted using the statistical analysis computer program Number Cruncher Statistical System (NCSS).9
Participant Eligibility: Of the four
study sites, five of the 43 participants (12%) questioned for
eligibility into the study were excluded. Reasons for exclusion were
that three participants had an initial BMD measurement (T-score) of less
than −2.5 without prior diagnosis of osteoporosis; one participant had a
history of kidney stones; and one participant had a history of bone
spurs (calcium was not recommended per participant’s primary care
physician). Of the 38 eligible participants, 37 (97%) were 50 years of
age or older and 1 (3%) was <50 years.
Assessment of Initial Supplementation Intake: Seventy-four
percent of all eligible participants (28 out of 38) were either not
taking any calcium and vitamin D supplementation, were taking
inappropriate amounts of supplementation (TABLE 2), or were using
a less effective calcium salt due to an acid reducer (i.e., PPI) or
salt causing constipation. Thus, a community pharmacist intervention was
required for 28 (74%) of the eligible participants.
Assessment of Supplementation Compliance After Pharmacist Intervention: Of
the 28 participants who initially required a pharmacist’s intervention,
15 returned for follow-up at 3 months. Nine of these participants (60%)
reported compliance with supplementation after the intervention
compared to none (0%) at the initial visit, a statistically significant
increase (P = .003). At 6 months, 8 participants returned for
follow-up. Four of these participants (50%) continued to be compliant
with what was originally recommended compared to none (0%) at the
initial visit, a statistically significant increase (P = .046).
Assessment of BMD After Pharmacist Intervention: Of
the 28 participants who initially required a pharmacist’s intervention
and whose BMD was measured at the initial visit, 15 returned for
follow-up at 3 months (TABLE 3). Nine of these participants (60%)
had an increase or no change in BMD compared to none (0%) at baseline, a
statistically significant increase (P = .001). At 6 months, 8
participants returned for follow-up. Five of these (62.5%) had an
increase in BMD from the 3-month follow-up, a statistically significant
increase (P = .026); and 4 of these 8 participants (50%) had an increase in BMD compared to none (0%) at baseline (P = .077).
According to the U.S. Preventive Services Task Force, no
studies have evaluated the optimal timing for repeated screening;
however, BMD testing may be needed for a minimum of 2 years to measure
any change.5 This current study indicates that 3 to 6 months
may be a sufficient time to show a positive change in BMD; however,
results should be interpreted with caution because of study limitations
(i.e., small patient population, numerous drop-outs).
Assessment of Satisfaction of Overall Service Provided by the Community Pharmacist: Of the 38 eligible participants, 13 (34%) completed an exit survey (FIGURE 1).
Based on the survey results, most participants answered, “strongly
agree” for the following question: “I found this service beneficial to
me in the management of my osteoporosis.” Most participants answered
“agree” for the following questions: “I learned how to manage my
osteoporosis with this study;”
“I would recommend this service to someone I know;” “I would be
willing to pay for this service in the future;” and “I would be
interested in continuing osteo-porosis counseling, education, and
monitoring by a pharmacist.” In addition, most participants indicated
that they would be willing to pay “less than or equal to $10” for the
According to the NOF, men and women over the age of 50 years require 1,200 mg of calcium and 800 to 1,000 IU of vitamin D.1
All participants with the exception of one woman in this study fell
into this age category. Participants’ intake of supplementation can be
seen in TABLE 2. Initial findings of this study indicate that the
majority of women were not taking the correct, if any, amount of
calcium and vitamin D supplementation despite the proven necessity of
such supplementation in reducing the risk of fractures.1 Some
women were also unaware of the absorption issues with calcium
supplementation. Absorption of calcium, depending on stomach acidity, is
between 500 to 600 mg per dose. Of the 38 eligible participants, 9
participants were on an acid-reducer (e.g., PPI or H2-antagonist)
at baseline. A number of women studied were taking 1,200 mg of calcium
once daily, resulting in an inappropriate total amount absorbed. Women
were also under the impression that they were receiving the full
benefits of calcium from taking 1,200 mg in a single dose.
Through this study, participants who were not taking the
recommended amounts of combination supplementation or who needed to
separate their calcium supplementation intake into two doses were
identified. Most of these women were not aware of the calcium salt
differences and thus were not using the most appropriate formulation. A
pharmacist’s intervention proved beneficial in identifying those
participants on acid-suppressing medications and in modifying calcium
supplementation to an alternate formulation.
A majority of participants (60% in the community
pharmacies, 57% in the senior centers) who returned for follow-up at 3
and 6 months showed an increase in compliance to calcium and vitamin D
supplementation after a community pharmacist’s intervention. This study
supported previous results indicating that pharmacists have the
opportunity for, and are beneficial to the community in, screening women
at risk of osteoporosis as well as increasing medication compliance.
Study results showed participant compliance in more than
half of the study population after a pharmacist intervention. Results
also indicate that in about 67% of participants, BMD increase after 3
months may be due to compliance with supplementation. About 50% of
participants who returned in 6 months showed an increase in overall BMD
from the initial visit. Previous studies reported that more research is
needed to correlate compliance of supplementation with the effects on
BMD. Even though this study may have shown a correlation between calcium
and vitamin supplementation compliance and increased BMD, more studies
The patient population within this study was relatively
small, although a surplus of participants was included to show
statistical significance (38 vs. 36). Additional and larger studies may
be warranted to show the positive role a community pharmacist’s
intervention has on supplementation compliance and increased BMD.
In addition, BMD data may have been skewed. Initial and
follow-up BMD measurements were recorded; however, it was not recorded
which heel, left or right, was measured by the Sahara Clinical Bone
Sonometer. This could possibly have had an effect on reported data due
to the fact that BMD in each heel may vary. Results could also have been
skewed as a result of other recommendations made by the PI, such as
modification of all life-style and diet risk factors associated with an
increased risk of osteoporosis. Last, favorable BMD results could also
have been caused by increased compliance with bisphosphonate therapy
Compliance with supplementation at 3-month and 6-month
follow-up was assessed based on a self-reported response. Participants
were asked open-ended questions as to the amount of supplementation
being taken. No standard compliance assessment tool was used, which
might have been a more appropriate tool in assessing compliance.
Finally, data may have been biased because recruitment
methods were not uniform across all settings. The recruitment methods
differed, as there was no real-time computer system at each of the
senior centers. These settings had to rely on different recruitment
methods from the community pharmacy settings, such as one-on-one
medication counseling. This may have biased the results because
participants may have been more willing to follow-up with the
pharmacist, since all members of the senior centers were provided other
services outside of the study.
The majority (74%) of participants in the study were
either not supplementing with calcium and vitamin D, were taking
inappropriate amounts of supplementation, or were using a calcium salt
with less absorption caused by other medications the participant was
taking (i.e., PPI) initially. A community pharmacist proved beneficial
in identifying and recommending appropriate amounts and types of
supplementation for those at osteoporosis risk and on bisphosphonate
therapy. Intervention by a community pharmacist proved beneficial for
compliance with appropriate amounts of calcium and vitamin D
supplementation, and appropriate intakes of supplementation showed
increased BMD at 3 months and 6 months. Averaging each question on the
survey that the participants completed, most participants believe that
the service was beneficial and helped to manage their osteoporosis. Most
participants would recommend the service to someone they know.
Participants would be willing to pay $10 or less for the service in the
future. More studies are warranted to demonstrate if OTC supplementation
can increase BMD.
The authors would like to acknowledge Professor Gary
Tataronis, Statistician, Massachusetts College of Pharmacy and Health
Sciences, for his contribution to this study.
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3. Office of Dietary Supplements, National Institutes of
Health. Dietary supplement fact sheet: vitamin D (health professional
version). June 24, 2011.
August 6, 2012.
4. Arvold DS, Odean MJ, Dornfeld MP, et al. Correlation of
symptoms with vitamin D deficiency and symptom response to
cholecalciferol treatment: a randomized controlled trial. Endocr Pract. 2009:15:203-212.
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for osteoporosis in postmenopausal women: recommendations and
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